TÜV Rheinland Blog

What's Behind the Listed Mark?

Posted by Hope Mascott on Mon, Apr 20, 2015 @ 11:05 AM

When Authorities Having Jurisdiction (AHJs) are out in the field inspecting equipment, they, no doubt, come across a wide variety of listed marks. Naturally, one or more of them are most familiar and so it makes sense that an AHJ inspector will look for them and question the validity of less well-known marks. However, listed safety marks are absolutely equal in their message and meaning.

UL, CSA, ETL and TÜV Rheinland listed marks are all valid certification marks demonstrating that a product has met the minimum requirements of widely accepted product safety standards. Each of these marks is issued by a Nationally Recognized Testing Laboratory (NRTL), an independent laboratory approved by the Occupational Safety and Health Administration (OSHA) to test products to the specifications of applicable safety standards. An NRTL's function is to provide independent evaluation, testing, and certification of any electrically operated or gas- and oil-fired product. (For more information about the NRTL program, visit www.osha.gov.)

All NRTLs, including TÜV Rheinland, can test products to a variety of the US and international standards, including UL standards. The misconception that UL is the only testing provider that can test to the UL standards might stem from the history of product safety testing in the US. At the start of its workplace safety and health program, the US government granted a testing monopoly to UL through the OSHA. In 1989, the US program was changed to a competitive model, and the role of an NRTL was created. The change came largely in response to pressure from the US industry groups whose members sold products in the European Union. Because of Europe's competitive regulatory market, in the early '80s, it was possible for US manufacturers to introduce their products to the European market twice as fast as they could introduce them to the US market.

The bottom line is that any NRTL’s mark is an accepted and recognized demonstration of product compliance. Any refusal to accept a specific certification mark could be considered a restraint of trade.

TÜV Rheinland is recognized as an NRTL in the US by OSHA, as a Testing Organization and Certifying Body by Standards Council of Canada, and as a Notified Body in Europe. The organization conducts evaluations to the UL, ANSI, CSA and NFPA standards as well as to the National Electrical Code and Canadian Electrical Code, andCanadian Electrical Code and SPE 1000 requirements.

TÜV Rheinland is a member of International Association of Electrical Inspectors, International Conference of Building Officials and American Council of Independent Laboratories.

To learn more about TÜV Rheinland mark, visit www.tuv.com/us, email info@tuv.com or call (888) 743-4652.


Topics: Commercial

New PAH Requirements for GS Certification

Posted by Bindu Subramanian on Wed, Apr 15, 2015 @ 10:15 AM

by Scott Sagamang, Business Development Manager - Environmental Services, TUV Rheinland of North America.

ChemicalsThe GS Mark is a voluntary certification mark that is used by manufacturers of consumer products of various kinds, and is accepted as the benchmark product safety certificate for exports to Germany. Effective 2008, the determination of the presence of Polycyclic Aromatic Hydrocarbons (PAH) in products is required in addition to the required safety tests. Although this is a voluntary standard, it has become the de-facto standard to limit PAH in all products exported to Germany. 

Effective 1 July 2015, a new set of PAH requirements under ProdSG will be implemented for all GS projects. This requirement was published by the German Committee for Technical Equipment and Consumer Products (Federal Institute for Occupational Safety and Health) in August 2014. The new AfPS document will replace the ZEK 01.4-08 as of 1 July 2015.

While the analytical test conditions remain largely untouched, the new requirements offer an entirely new set of specifications for PAHs. The new requirement has implemented the latest REACH Annex XVII (Item 50) Restriction of PAH for toys and other consumer products. The overall limits and categorization rule has been modified to further minimize the possible chemical hazards associated with these chemicals.

A quick look at some of the main changes:

  1. Change to Scope: Inclusion of all toys with intended or prolonged skin contact
  2. Increased limits in Category 1 for certain PAH’s
  3. Limits have been strengthened for products under Category 2 and 3.
  4. Timeline for compliance

Affected Product Categories

  • Electrical and electronic products 
  • Toys
  • Food packaging materials 
  • Plastic products 
  • Rubber products 
  • Machinery 


According to the new requirement, GS Mark certificates that are issued before July 1, 2015 will initially retain their validity. However, as a regular control measure to monitor the manufacturing process, if the product does not comply with the latest requirement at its next inspection, then the GS mark will be withdrawn immediately. Example, validity to the old requirement is to be transitioned between 1 year and 2 based on factory inspection frequency.

About PAH’s

Polycyclic aromatic hydrocarbons, also known as PAHs (and sometimes polyaromatic hydrocarbons) are a group of over 150 chemicals which are typically produced during the manufacturing process and are not intentionally added to consumer products. This group of structural substances are suspected to have or proven to have in some cases, carcinogenic properties. 

To read the detailed test limits, click here.

TÜV Rheinland can test and evaluate now to these stricter and more defined PAH concentration limits to prevent withdrawal of your current GS licenses due to non-compliance. Please contact us today for more details.

Contact us today!

Call us at 1-888-743-4652 | Email Us | Request Quote

Topics: RoHS/REACH, Green Services

Regulation (EU) 1272/2013 REACH amendment of PAH

Posted by Bindu Subramanian on Mon, Mar 16, 2015 @ 09:30 AM

by Scott Sagamang, Business Development Manager - Environmental Services, TUV Rheinland of North America.

REACH Regulation

Polycyclic aromatic hydrocarbons, also known as PAHs (and sometimes polyaromatic hydrocarbons) are a group of over 150 chemicals which are typically produced during the incomplete burning of coal, oil, gas and other organic substances. Some examples of PAHs include: naphthaline, anthracene, phenanthrene and pyrene. Most PAHs are considered carcinogenic, mutagenic and harmful to the reproductive system. They target fat tissues, the kidneys and the liver most often.

PAHs exist in a wide range of petrochemical products such as plastic, rubber, crude oil, lubricant, rustproof oil, form release agents, mineral oil and tar, and in daily chemicals such as pesticides, charcoal, germicides and mosquito-repellent incense. They can also be found in medicines and dyes. PAHs can also be man-made. Grilling or charring food at home, burning a wood fire or even breathing in cigarette smoke can expose you.

PAHs present a problem because they do not burn off easily, leading to a longer stay in the environment.  Although some can turn into a vapor in the air, most do not break down easily in water. Exposure to PAHs can occur with skin contact, ingesting of contaminated air or eating/drinking contaminated food or water, and they typically leave the body within a few days through feces or urine.

It’s estimated that exposure to 3 mg/day of PAHs will not cause any long-term health issues. However, studies have shown prolonged exposure over a significant amount of time might cause cancer and difficulties with reproduction. 

The Commission Regulation (EU) No 1272/2013 was published in official journal of European Union on 07 Dec 2013. This new regulation amended Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) as regards Polycyclic Aromatic Hydrocarbons (PAHs). Under the REACH Regulation (EC) No 1907/2006 Annex XVII, Entry 50, eight PAHs have long been restricted in extender oils used in tires. The same eight PAHs are now subject to the new requirements added by two new paragraphs in the new regulation.

On December 27, 2015 The Commission Regulation (EU) No 1272/2913 will go into effect.

What to Know: Key Amendments

  • Articles with direct as well as prolonged or short-term repetitive contact with the human skin or the oral cavity, made of plastic and rubber shall not contain more than 1 mg/kg (0.0001 % by weight of this component) of any of the listed PAHs
  • Such articles can include:
  • Sport equipment such as bicycles, golf clubs, racquets
  • Household utensils, trolleys, walking frames
  • Tools for domestic use
  • Clothing, footwear, gloves and sportswear
  • Watch-straps, wrist-bands, masks, head-bands
  • Toys, including activity toys, and childcare articles, shall not contain more than 0.5 mg/kg (0.00005 % by weight of this component) of any of the listed PAHs.

Name of PAH


Name of PAH


















Are you ready to comply with the new amendments?

Per the European Chemicals agency, “A restriction applies to any substance on its own, in a mixture or in an article, including those that do not require registration. It can also apply to imports.”  This new restriction means that your products that contain plastics or rubbers that are to be touched under normal use cannot have more than 1 mg/kg (0.0001 % by weight of this component) of any of the listed PAHs.  Analysis to confirm the content is imperative to prevent removal or banning of your products.  As this takes affect December 27, 2015, time is short and action may be required on your part to reformulate or substitute components.

TÜV Rheinland can test for these substances now.  Be proactive and contact us to prevent a hindrance to the EU market.

TÜV Rheinland is committed to offering you the latest updates in REACH. Our experts can offer you up-to-date information and recommend relevant test. Please contact us today for more details.

SOURCE: Commission Regulation (EU) No 1272/2013 Official Document

SOURCE: http://www.epa.gov/osw/hazard/wastemin/minimize/factshts/pahs.pdf

SOURCE: http://www.atsdr.cdc.gov/PHS/PHS.asp?id=120&tid=25

Topics: RoHS/REACH, Green Services

4th Edition of IEC 60601-1-2 Sets New EMC Requirements

Posted by Bindu Subramanian on Tue, Feb 24, 2015 @ 09:00 AM

by Bruce Fagley, TÜV Rheinland, EMC Technical Manager


IEC 60601-1-2

The fourth edition of the IEC 60601-1-2:2014 standard is out, introducing significant technical changes in electromagnetic compatibility (EMC) requirements and tests for medical equipment and systems. The revision mandates compliance of new products by April 2017 in the USA. In the European Union, the 4th edition is not yet published in the official journal so the mandatory date of compliance is not clear.  It is possible that this date may be set at August 2017, more information will be available in a few months. In the USA, existing products will need to comply if changes are made, effective, April 2017. The US Food and Drug Administration (FDA) already officially accepts the fourth edition, and there have been reports that the FDA is asking for it now on new 510(k) applications.

The main goal of the new edition is to ensure that the practice of science, medicine, and saving lives is not disturbed by common EMC phenomena.

Here are some key specifics:

  • The fourth edition changes the basic EMC compliance philosophy to define tests and limits according to risk and intended use instead of a device type. Tests are defined based on where the equipment will be used – either in a healthcare facility, at home (which includes almost everything except the healthcare environment) or in a special environment such as military, heavy industrial, or medical treatment area with high-powered medical equipment and will be tested in accordance with its intended use.
  • The revision recognizes that for special environments, immunity test levels higher or lower than those specified for the professional healthcare and home environments might be appropriate.  As an example, a product that is always used in a humidity controlled environment may be allowed to meet lower ESD immunity levels.
  • The edition introduces new safety engineering into medical EMC/ Risk Management. The title of the standard is now “General requirements for basic safety and essential performance.”  The product risk analysis must now include risk from EMC disturbances.
  • Products will be subjected to increased immunity test levels to minimize the risk of electromagnetic interference: for example, the ESD test levels are increased to 15KV air and 8KV contact, almost double the current specifications. The levels of conducted immunity testing are now increased to 6v in the ISM frequency bands.
  • Another significant change from the existing requirements is the new wireless proximity test, which increases the radiated immunity test levels to 28V/m at some frequencies. These levels are increased to evaluate the products susceptibility to interference from common wireless devices.  All products must comply with the new test.
  • The standard restricts the use of lower immunity levels for compliance. The new annex “E” describes the process for determining the immunity test levels for products used in special environments where different immunity levels could be justified.
  • Manufacturers will need to prepare a test plan/risk analysis prior to testing. Clause 6.2 requires that an EMC test plan be provided to the EMC test lab, additional guidance on preparing a test plan is found in annex “G” of the standard.

Advance planning is critical for compliance, especially if a manufacturer has multiple products, all of which will eventually need to be re-tested to the new requirements.  Manufacturers are advised to review the design of their products now to determine if any changes will be required to ensure timely compliance. The manufacturer must be aware that when developing the risk analysis, all EMC risks present in the environment of use must be considered.  This may require testing to additional EMC standards like IEC 61000-4-16, MIL-STD 461 etc. 

TÜV Rheinland's expert services can help you take advantage of everything IEC 60601-1-2:2014.  Starting your transition early allows you to ensure your medical device safety testing will comply with standards worldwide, and reduce the risk of company liability by meeting approved safety standards.

Contact us to get a head start in your transition process and reap the hidden benefits of IEC 60601-1 Standard.

Topics: EMC, Medical, IEC 60601

Green Blog Series: What’s changing in China RoHS?

Posted by Bindu Subramanian on Wed, Feb 18, 2015 @ 01:30 PM

TUV Rheinland of North America is excited to annouce our 2015 Green Blog Series. TÜV Rheinland experts and industry veterans, Geoffrey Bock and Scott Sagamang will be presenting you with a new timely blog each month on the most up-to-date "Green" topic.

Meet our experts!

Scott SagamangScott Sagamang, Business Development Manager - Environmental Services, TUV Rheinland of North America.

In his current role, Sagamang specializes in assisting companies with global environmental requirements. His background includes extensive experience with machinery manufacturing, retrofitting, machine control and machinery safety. 

He has extensive knowledge on EU RoHS, WEEE, China RoHS, EU REACH, PAH, LFGB, XRF and Chemical Analysis, CalProp65, CPSIA as well as product lifecycle management.

Geoffrey Bock

Geoffrey Bock, Director - Green and Environmental Services, TUV Rheinland of North America.

A 15 year veteran of TÜV Rheinland, Geoffrey is intensely involved in educating and training manufacturers on the RoHS, REACH and WEEE directives. 

He is a “Substances of Concern” task group leader for the NSF 426 ELSS (Environmental Leadership Standards for Servers) standard development committee. His experience in manufacturing, supply chain sustainability and a broad knowledge of environmental restrictions helps customers understand the hurdles they have to navigate through in order to prove compliance. He often provides training and seminars for clients globally.

Our first installment in our monthly blog series is on the current changes to China RoHS!

REACH ChemicalsDid you know that a revised marking standard was implemented on January 1, 2015?  SJ/T 11364-2014-2006 is now replaced by SJ/T 11364-2014.  The new title of the standard is “Marking for the Restricted Use of Hazardous Substances in Electronic and Electrical Products”.

Let’s take a look at the comparison of the major changes between the 2006 version and the 2014 version as cited in the English version:

  • Most noticeable update is a name and applicable scope changes.  “Electronic information products” is now changed to “electronic and electrical products”.  Also “pollution control” has been changed to “restricted use of hazardous substances”.
  • An explanation for the reference application in logistics processes has been added.
  • Reference to Chinese Standard GB 18455 has been deleted from the standard
  • Definitions and terms for “electronic and electrical products”, “hazardous substance”, and “logistics” have been added.
  • Also, digital format options have been added for electronic and electrical products with display functions.
  • Deletion of the name labeling requirements for packing materials.
  • One should also note that EEP (electronic and electrical products) now have rated working electrical voltages limitations for both AC and DC.
  • A section that specifies the conditions that must be met if using the digital format mark.
  • The clause 6.2 table has a new reference to the option of adding an explanation of when you choose to add “X” for a particular part name and hazardous substance.

RoHS label resized 600As you might notice, the Chinese standard is starting to look more and more like something you would see as part of EU RoHS.  There is discussion of the scope of products  may be moving to a similar product scope as seen with EU RoHS.  The ministry law has not officially been updated, thus the standard is said to be in abeyance until that time.

Now is the time to understand what this can mean for your products.  Realize that this could happen at some point in the near future.  It is not uncommon for the new law to be implemented without notice.  If the product scope changes and you must comply, can you react quickly?  Do you have a solution to implement this quickly without loss to market?  TÜV Rheinland is a service provider that can react quickly and assist with providing the due diligence you need to prevent product flow stoppage.

Contact us today!

1-888-743-4652 | Email Us

Topics: RoHS/REACH, Green Services

Draft Commission Directive amending Annex II to RoHS Directive (2011/65/EU)

Posted by Bindu Subramanian on Mon, Feb 02, 2015 @ 10:25 AM

REACH ChemicalsOn December 17, 2014, the European Commission notified the World Trade Organization (WTO) that it will be adding four additional substances to the EU RoHS Directive (2011/65/EU). This will be done as a Delegated Directive amending Annex II (list of restricted substances) of the RoHS Directive.

Four phthalate substances will be added to the RoHS substance restrictions. Phthalates are primarily used as plasticizers in plastics, particularly in PVC plastic which is commonly used for wires and cables but can also be found on some electronic components or other plastic parts.

The restrictions take effect beginning on July 22, 2019 and most products will need to comply including medical devices, by July 22, 2021. Click here to read the release in detail.

It is expected that the additional 4 Phthalates added to the RoHS Directive will add stress initially to supply chain management, as new declarations of conformity for their part numbers will be required.

Risk assessments and testing of high risk parts will be required according to EN 50581 (RoHS – Technical Construction File requirements)

TÜV Rheinland is committed to offering you the latest updates in Green Compliance (REACH, RoHS and WEEE). Our experts can offer you up-to-date information and relevant test. Please contact us today for more details and our service offers.

Contact Us Today!

Topics: RoHS/REACH, Green Services, Medical, Commercial

Preventing Danger In Your Workplace

Posted by Jen Picardo on Fri, Dec 19, 2014 @ 10:37 AM

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TÜV Rheinland’s Environmental Health and Safety solutions bring qualified engineers, industrial hygienists, and occupational safety experts to your facility to ensure your operations and equipment meet Federal and State OSHA plans, NFPA standards, and ANSI or other applicable consensus standards and best practices.

In the year 2014, we saw several changes and revisions to workplace safety laws. Our experts wrote several timely blogs to keep you informed of these changes!

TÜV Rheinland's EHS Safety Resources

If you missed any of our blogs on Occupational Health and Safety, please click on the links below to read them!

Let TUV Rheinland of North America work with your team to help identify and eliminate or minimize occupational health hazards. Contact us today!

Topics: Environmental Health and Safety

6 New Substances Added to REACH Candidate List

Posted by Jen Picardo on Fri, Dec 19, 2014 @ 10:04 AM

On December 17, 2014, The European Chemicals Agency (ECHA) amended the Candidate List by adding six (6) new substances to the REACH Candidate list, bringing the total up to 161 substances. The following substances meet the criteria set out in Article 57 of the REACH Regulation.

 Chemical Test tubes

DEHP is now updated to reflect the additional reason for inclusion. Click here for more information on the newly added substances. 

TÜV Rheinland is committed to offering you the latest updates in REACH. Our Chemical expertise can offer you up-to-date information and relevant test. Please contact us today for more details and our service offers.

Topics: RoHS/REACH

Comprehensive Green Compliance Package for OEM Suppliers

Posted by Bindu Subramanian on Fri, Nov 07, 2014 @ 10:09 AM

RoHS/REACHOriginal Equipment Manufacturers (OEM’s) are constantly demanding full material disclosures on hazardous substances (FMDs), Declarations of Conformity (DoCs), Certificates of Conformity (CoCs) and/or test data that the part numbers meet the required RoHS or REACH requirements. This is the method by which most OEM’s declare compliance for their finished product.


Going Global

Several countries globally are implementing Restriction of Hazardous Substances (RoHS) regulations and REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) regulations in order to restrict the use of harmful chemicals and toxins in their electrical and electronic products.

Regions that have stringent rules at this time include:

  • European Union / RoHS Directive
  • China / Administration of the Control and Electronic Information Products or commonly referred to as China RoHS
  • Korea / Administration of the Control and Electronic Information Products
  • California / (Electronic Waste Recycling Act of 2003)
  • and more….
Products intended to be marketed or sold in Europe MUSTcomply with REACH and RoHS regulations.

RoHSWhat is RoHS?

RoHS is the EU Directive that restricts the use of certain hazardous substances in electrical equipment and electronic products (EEE products), including components and/or sub-assemblies.

Who does RoHS affect?

Any business that uses any of the restricted materials and plans to sell its products in RoHS countries, through any sales channel (direct, distributor, integrator, reseller etc.), is affected by the RoHS Directive. Failure to comply with the RoHS regulations can result in severe fines and could result in immediate removal of product from the EU marketplace.

Since 2004, the EU legislation restricts the use of hazardous substances in electrical and electronic equipment (RoHS Directive 2002/95/EC) and promotes the collection and recycling of such equipment (WEEE Directive 2002/96/EC). Products placed on the EU market as of July 1, 2006 must pass the RoHS Compliance.

The objective of the legislation was also to increase the recycling and/or re-use of such products and restrict the use of heavy metals like lead, mercury, cadmium, and hexavalent chromium, as well as flame retardants such as polybrominated biphenyls (PBB) or polybrominated diphenyl ethers (PBDE).

In 2011, the EU amended the RoHS scope, also known as RoHS2. The recast European RoHS Directive (2011/65/EU), restricts the use of certain hazardous substances in electrical and electronic equipment. The recast directive repealed the Directive 2002/95/EC with effect from 1 July 2011. The EU has also released an exemptions update, allowing the use of some of the restricted chemicals for specific purposes. (Click here to read more)

RoHS II is also a CE Mark Directive, effective January 2, 2013 and the transition is expected to be complete in 2019. The directive applies to products that are “dependent on electric current or electromagnetic fields for at least one intended function”.

Requirements include:

  • Technical testing and accompanying documents
  • A declaration of conformity
  • CE marking affixed to the product.

Similar to the RoHS requirements, the EU REACH regulation is also mandatory for products being exported to Europe.


Registration, Evaluation, Authorization and Restriction of Chemicals or REACH is considered to be the strictest law to date regulating the use of chemical substances. REACH is a European Community safety regulation that implies that "no data, no market" companies can only launch their products on the market or use them if these chemicals are properly registered. EU REACH started its 10 year, phased implementation on June 1, 2007.  The current REACH regulation for “articles” includes 155 substances of very high concern (SVHC’s). For a complete list, please click here.

One of the major elements of the REACH regulation is the requirement to communicate information on chemicals throughout the supply chain. The REACH regulations affect manufacturers, importers, downstream users and companies established outside the EU. The end use of chemicals affect various industries from consumer goods to personal care to industrial use. Here is a short list of some other industries affected:

  • Chemical Industry
  • Petroleum Processing
  • Plastics Processing
  • Optics
  • Engine/Plant Production
  • Fine Mechanics
  • Recycling
  • Cosmetics
  • Food
  • Furniture
  • Sports Equipment
  • Toys
  • Leather and Drapery
  • Printing

REACH Pre-Registration

The European Chemicals Agency has set three major deadlines for registration of chemicals:

  • December 1 2010 - 1000 tons/year
  • June 1, 2013- 100 tons/year
  • June 2, 2018 - 1 ton/year

Pre-registration is the process for potential EU registrants to inform the European Chemicals Agency (ECHA) of their intent to register phase-in chemical substances.  The EU REACH Pre-Registration initially took place between June 1 and December 1, 2008, during which time about 143,000 chemical substances marketed in the European Union were pre-registered. The pre-registration was later extended to potential registrants who manufacture or import a phase-in substance in quantities of one ton per year or more to benefit from the extended deadlines. Click here to read our blog on this topic.

Similar to RoHS, even if you don't do business in Europe, you are not off the hook. Following the EU regulation, countries such as China, Malaysia, Japan, and Turkey have already implemented REACH-like legislation. Several other countries are following suit including South Korea which will unveil its REACH regulation “K-REACH” in January 2015.


Green Compliance for SuppliersTÜV Rheinland’s Green Solutions Goes to Work for You

REACH and RoHS compliance poses a big challenge for most companies and requires extensive and specific technical competence and knowledge.


We want to be your partner in ensuring your materials and parts are in compliance. We will assist you with risk assessment of materials, identifying potential high risk materials requiring testing and/or help with validating DOCs and CoCs. Our test lab in North America is ISO 17025 approved through A2LA, accredited for many types of material and product testing and is located in Bentonville, Arkansas.


We employ RoHS, REACH, CPSC, WEEE and other legislation experts that can assist you with your educational needs as well as consult on compliance requirements and solutions. To learn more click here to download our complete brochure or our handy infographic!


 Source: http://ec.europa.eu/environment/waste/rohs_eee/pdf/faq.pdf

Topics: RoHS/REACH, Green Services, regulatory compliance

Connected Health Conference in Boston Draws Stakeholders from the US and Abroad

Posted by Hope Mascott on Wed, Nov 05, 2014 @ 03:23 PM

Boston recently played host to an international crowd of innovators, public officials, patient groups, academics and entrepreneurs with a vested interest in Connected Health. They gathered at the 5th EU-US eHealth Business Marketplace & Conference held at the Boston State House on October 21-22.

The conference focused on innovations in e-Health, IT Health and Connected Health, a model for healthcare delivery that uses technology to provide healthcare remotely. The theme was “Transforming Care and Accelerating Economies.”

TÜV Rheinland’s Geoffrey Bock and OpenSky’s Mark Coderre attended the conference to learn from the international leaders in Connected Health and share their own expertise as part of the panel on “Medical Device Suite of Standards – to What Degree Does Regulation Help or Hinder Innovation?”

Coderre discussed the ever-increasing need for cybersecurity in embedded in the development lifecycle and final product for medical devices. He also reviewed and acknowledged the importance of the principles laid out in the FDA's guidance in the United States. Bock explained the need for risk assessments that help OEMs meet the standards applicable to the current EU Directives.

“Regulations, standards, risk assessments and due-diligence all help keep patients, doctors, clinics and insurance companies safe when they accept new and innovative devices that might pose high risk precisely because they are so groundbreaking,” summarized Bock.

The conference provided workshops, networking with IT Health professionals, and the chance to establish new business relationships in pre-arranged matchmaking sessions. The partnership between Ireland and the US is particularly promising and was highlighted through a direct “Sister City” relationship between Belfast, Ireland, and Boston.

“It was great to see how many countries were present at this show, and the relationship that Boston has with Belfast was clearly evident through the number of representatives,” said Bock. “It was a great message to other countries that working together across the Atlantic is not only possible but very rewarding.”

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The “Shark Tank” session, which allowed innovators to present their ideas in search for funding, showcased some unique offerings, most of which, used phones, tablets and apps to provide the new product, confirming the trend toward using Wi-Fi, 3G/4G and Bluetooth technologies in medical innovations.

To learn more about testing of Connected Health devices, email TÜV Rheinland at info@ tuv.com.


Topics: Medical, Cybersecurity, FDA