Six Complimentary Seminars and Webinars to Help Manufacturers Keep Abreast of Current Global Regulatory Requirements
TÜV Rheinland is hosting a series of free International Approvals (IA) webinars and seminars on the global regulatory approval of products. Professionals involved in legal placement of products in global markets, including marketing, compliance and engineering staff, are invited to participate in the discussions that will include: Global certification planning and management, updates on regulatory changes in key countries, final in-country product registration services, and more. These solutions cover more than 200 countries and a broad range of products.
The presenter is Bill Holz, Electric Business Field Technical Manager for Market Access/IA at TÜV Rheinland. He has over 30 years of experience in international regulatory services and is an expert in the rules and pitfalls of navigating complex international regulatory procedures. In addition, our experts from Brazil and China will be in North America to co-present at the seminars in California and Massachusetts.
The seminars are scheduled in three locations throughout the country and will take place from 8:30 a.m. to 3 p.m. and include continental breakfast and lunch.
The seminar dates and locations are:
- IA Briefing on Brazil --- June 20 – Pleasanton, CA
- IA Briefing on China/ Taiwan -- September 17 – Pleasanton, CA
- IA Briefing on China/Taiwan -- September 19 – Boxborough, MA
These webinars are scheduled from 2—3:00pm ET
- IA Briefing on Mexico – June 18
- IA Briefing on Russia/Customs Union – August 6
- IA Briefing on Australia/New Zealand – November 12
Call: 1-888-743-4652 or email info@us.tuv.com.
TUV Rheinland of North America will host a free Smart Grid Educational Series seminar and a webinar on Tuesday, May 28, 2013. The event is made possible through the collaboration with Erfan Ibrahim, Ph.D., founder of The Bit Bazaar LLC’s webinar series.
The keynote speaker Chris Villarreal, from the Policy and Planning Division of the California Public Utility Commission (CPUC) will be discussing the commission’s newly published policy on cyber security. This comes at an appropriate time give the forward momentum of TUV Rheinland into cyber security space.
The meeting will provide an opportunity for the industry stakeholders in the Silicon Valley area to network with peers, view a demo of Smart Grid technologies, and tour TÜV Rheinland’s Smart Grid Test Laboratory.
The webinar will be streamed to the global audiences at 1 p.m. PST, and the in-person seminar is scheduled from 12 – 2:30 p.m. PST at TÜV Rheinland’s Smart Grid Test Laboratory at 1279 Quarry Lane, Pleasanton, Calif. To register for the webinar or seminar, please email us or click on: http://education.tuv.com/smart-grid-educational-may-28
"TÜV Rheinland is continuing to grow its business in the Smart Grid market," said Sarbjit Shelopal, North American Field Manager at TÜV Rheinland. "Our ZigBee and Wi-Fi Alliance certification marks, along with many Safety, ANSI and FCC test suites, are just part of testing we perform to support manufacturers and utilities providing Smart Grid technologies to consumers.
“We are pleased to work closely with our friends at TÜV Rheinland out of Pleasanton and will soon also use their new facility opening in Irvine, Calif., for the meeting of our Southern California colleagues,” Dr. Erfan Ibrahim said.
Dr. Ibrahim serves as Principal Consultant, Energy Sector Practice, at Scitor Corporation in Sunnyvale, Calif.,
www.scitor.com.
On May 1st, Sandia National Laboratories and Electric Power Research Institute (EPRI) are hosting the 2nd PV Performance Modeling Workshop at the Biltmore Hotel in Santa Clara, CA.
This 2 day symposium/workshop provides professionals with information on advances in modeling, on pathways to reducing variability in model input and output, and on opportunities for standardizing modeling practice and reducing project risk.
Dr. TamizhMani will be speaking on May 1st at 3:00pm on “Performance Matrices per IEC 61853 standards: Their Importance for the Energy Estimation Models.” His presentation is based on the works performed at Arizona State University and TUV Rheinland PTL.
He will cover the following topics:
- Scope and objectives of the newly developed IEC 61853-1 standard
- Generation of performance matrices using IEC and Sandia methods
- Importance of these matrices for the energy estimation models used by the industry
- Scope and objectives of the DRAFT IEC 61853-2 standard
- Influence of angle of incidence (AOI) on the performance of PV modules
- Importance of AOI influence for the energy estimation models used by the industry
DETAILS ON THE EVENT:
Wed., May 1-- Thurs. May 2, 2013
The Biltmore Hotel
2151 Laurelwood Road, Santa Clara, CA
May 1--2, 2013
Dr. Mani TamizhMani, President of TUV Rheinland Photovoltaic Testing Lab (PTL) from Tempe AR, will be a presenter. TUV Rheinland is a global leader in testing, inspection, and certification, covering a wide range of testing services, including solar PV. Dr. Mani has over 30 years of experience in solar PV, and is a member of various standards developing organizations. He has published more than 40 peer papers in journals and speaks at numerous national and international conferences.
TUV Rheinland of North America will host a free Smart Grid Educational Series seminar and a webinar on Tuesday, April 2, 2013. The event is made possible through the collaboration with Erfan Ibrahim, Ph.D., founder of The Bit Bazaar LLC’s webinar series.
The keynote speakers Tom Tansy and John Nunneley, founders of The SunSpec Alliance, will discuss securitization of solar assets, and TÜV Rheinland experts will provide an update on the Consortium for Smart Energy Profile 2.0 (CSEP2.0) specification certification.
Network with peers, view a demo of Smart Grid technologies, and tour TÜV Rheinland’s Smart Grid Test Laboratory. The seminar is scheduled from 12 – 3:30 p.m. PST at TÜV Rheinland’s Smart Grid Test Laboratory at 1279 Quarry Lane, Pleasanton, Calif. To register for the webinar or seminar, click here.
If you can't make it to the seminar, there will be a webinar streamed to the global audiences at 1 p.m. PST. Register here.
The keynote presentation by Tom Tansy and John Nunneley will explore the requirements of securitization, including assessing the risk associated with solar plant performance. The speakers will identify key plant measurements and performance indicators that drive the actuarial data needs of financiers to determine the health, reliability, and long-term performance of solar assets.
“Currently, most financing is done by a relatively few participants with large tax equity appetites,” explained Tom Tansy. “With the Investment Tax Credit scheduled to be reduced from 30% to 10% in 2016, new sources of capital are needed. An accurate risk assessment is essential to the securitization effort where solar assets are bundled into tradable investment products.”
"TÜV Rheinland is continuing to grow its business in the Smart Grid market," said Sarbjit Shelopal, North American Field Manager at TÜV Rheinland. "Our ZigBee and Wi-Fi Alliance certification marks, along with many Safety, ANSI and FCC test suites, are just part of testing we perform to support manufacturers and utilities providing Smart Grid technologies to consumers. As a member of The SunSpec Alliance, TÜV Rheinland is also focused on the interoperability of the inverter industry adhering to SSA 2.0 specification.”
“We are pleased to work closely with our friends at TÜV Rheinland out of Pleasanton and will soon also use their new facility opening in Irvine, Calif., for the meeting of our Southern California colleagues,” Dr. Erfan Ibrahim said.
Dr. Ibrahim serves as Principal Consultant, Energy Sector Practice, at Scitor Corporation in Sunnyvale, Calif., www.scitor.com. Previous webinars covered such topics as Distributed Energy Resources, Smart Grid Cybersecurity, XMPP for the Smart Grid, RF Safety of Smart Meters and Smart Grid Network Management.
On April 12th, the SEMI Arizona Breakfast Forum will be held in Chandler, Arizona. Iindustry experts will discuss the Impact of Emerging Technologies on Device Manufacturing.
What technologies are on the horizon? What will it take for more rapid implementation? How will it impact the way we do business?
The rapid deployment of new technologies in a broad range of products makes it even more challenging to keep pace with today’s expanding device manufacturing demands. The SEMI Arizona Breakfast Forum will explore emerging technologies for MEMS, Solar, and LED. Also included are Hands-On Demos on Intel's Ultrabooks, Tablets, Smartphones & more!
DETAILS ON THE EVENT:
Friday, April 12, 2013
Intel Corporation, Ocotillo Campus, OC2 Building
4500 S. Dobson Rd.
Chandler, AZ 85248
Dr. Mani TamizhMani, President of TUV Rheinland Photovoltaic Testing Lab (PTL) from Tempe AR, will be a presenter. TUV Rheinland is a global leader in testing, inspection, and certification, covering a wide range of testing services, including solar PV. Dr. Mani has over 30 years of experience in solar PV, and is a member of various standards developing organizations. He has published more than 40 peer papers in journals and speaks at numerous national and international conferences.
Register here for the seminar.
TUV Rheinland will be exhibiting and speaking at two round tables at the Medical Devices Summit - Boston. The show is taking place at the Boston Marriott Long Wharf, February 28-March 1, 2013.
Geoffrey Bock will be speaking on RoHS for the Medical Industry and Bill Holz will discuss International Approvals for the Medical Industry. To learn more about their presentations, read below!
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Geoffrey Bock is the Business Development Manager for Environmental Services for TUV Rheinland. He has been with the company for over 10 years. |
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The impact to medical device manufacturers by the recast of the Restrictions of Hazardous Substances Directive (RoHS 2)
The European Directive on the Restriction of the use of Certain Hazardous Substances in Electrical and Electronic Equipment (RoHS Directive 2002/95/EC) has been recast and superseded by a new Directive (2011/65/EU). Medical Devices and In Vitro Diagnostic Devices that were previously exempt from the Directive are now required to be compliant. The RoHS 2 Directive needs to be followed by manufactures of these devices offered on the European market. This workshop will provide an overview of the requirements and the impact on device manufactures who wish to remain in this market.
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Currently, Geoffrey is intensely involved in educating and training manufacturers on the RoHS / REACH and WEEE directives. He is also a committee officer (ASTM F40) for the development of new RoHS standards with the ASTM F40 standards committee that will globalize testing and measurement for substances in materials. |
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Bill Holz is the IA Operations Manager and IA Technical Manager for Market Access (International Approvals). He has been with TUV Rheinland of North America since August 2008.
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International Approvals for the Medical Industry
The development and placement of medical devices in the global market can be a complex task. The implications and possible consequences of failing to meet mandatory country requirements can pose serious risk for a company. It's important to learn about the key items which can cause delays in getting products to market and realizing revenues. Learn about requirements, essential planning, pitfalls and tips on how to avoid and overcome challenges associated with placing medical devices in a global market.
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Mick Howk recently joined TUV Rheinland of North America as the new Sales Manager for the Medical Division. Everyone at TÜV Rheinland is excited to welcome Mick to the team. He comes with more than 25 years of experience in the quality and regulatory field, having previously worked as a sales manager for medical devices at both The British Standards Institution and SGS. Addtionally, Mick has held faculty positions at Tidewater Community College in Virginia and the University of Phoenix in Arizona.
His years of experience, both in business and eduational settings, is a valuable asset to TÜV Rheinland. On the business side, he has helped a number of organinzations implement quality management systems and achieve certification for medical devices and In Vitro Diagnostic devices. And, as an educator, he provided instruction on management, process design, quality assurance and manufacturing.
Medical test and medical certification and audit remains one of the most highly regulated markets. It is here that Mick's knowledge and experience will help our customers the most. His extensive knowledge of regulations and manufacturers' needs will be a huge help to companies trying to get their medical devices to global markets efficiently and on time.
Mick holds a a Master of Science degree in Management from Troy University in Troy, Ala., and a Bachelor’s degree in Industrial Engineering Technology from Thomas Edison State College, Trenton, N.J. Additionally, he holds industry certifications in Regulatory Affairs (RAC-EU), Quality Engineering (CQE), Quality Auditing (CQA) and is a Six Sigma Black Belt (CSSBB).
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A Message From Mick
“I am pleased to have an opportunity to work with TÜV Rheinland’s skilled and self-motivated sales professionals and with a leadership team that has established a solid vision and strategy for the group.”
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Equipped with a Computed Radiography machine, TUV Rheinland Industrial Solutions made a house call this week to Pittsburgh’s oldest known building, the Fort Pitt Block House.
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The Block House will celebrate its 250th anniversary next year, and a preservation project was kicked off with an X-ray exam to determine the stability of the gun loop timbers. |
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Radiation safety director Chris Dugan and his crew X-rayed the wooden gun loopholes going around the building. During the French and Indian War, the loopholes provided a 360 degree view for the soldiers who were stationed in the Block House and could fire their muskets through them at anyone trying to attack. |
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TÜV Rheinland typically uses computed radiography to examine piping systems, tanks, pressure vessels and steel bridge components, though, now and then, the team gets a chance to X-ray a dinosaur or an old painting. This was the first time TÜV Rheinland X-rayed a historic building.
Check out TÜV Rheinland and the Fort Pitt Block House preservation efforts in the news:
CBS Local:
WTAE News:
Post Gazette:
Electrical and medical device manufacturers are finding it harder than ever to deliver products to the market. Labeling is especially complex. Not just all levels of packaging, but also Instructions for Use (IFUs), technical data sheets and other documents. Organizations must comply with global country certifications and there are at least 10 unique medical device codification systems in the EU alone.
Even more challenging is anticipating regulatory change. Electrical and medical device manufacturers are often given just months to comply with new regulations, at the risk at completely halting production. A detailed description of the current status of the FDA UDI regulations can be found here.
To help you understand the challenges many electrical and medical device manufacturers are facing, TUV Rheinland has developed a guide of best practices for Internaitonal Electrical & Medical Device Labeling. This guide will offer methods to respond to the various challenges, including how to ensure continued production and delivery, and adapting to changing regulatory requirements. Download our guide today!
By Ozgur Ozturk, Business Development Manager, EMC at TUV Rheinland of North America
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Under Electromagnetic Compatibility (EMC) Directive 2004/108/EC, electrical equipment sold in the European Union needs to follow the conformity assessment procedure in order to conclude with Declaration of Conformity and the CE mark. |
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Manufacturers need to test their equipment for EMC emissions, among other things. Under the EMC Directive, the permitted levels of emissions are specified in Harmonised Standards for products, product families or generic environments. EMC emission testing needs to demonstrate that the limits are met or, if they are not met, identify design modifications to ensure compliance.
What are the common remedies to high EMC emissions?
In particular, only some of the radiated emission problems are due to differential mode currents but most are due to common mode currents.
Also, there are simply three ways to look at the conducted emission problems:
- Coupled radiated emission noise
- Due to Logic
- Due to Power Supply
Possible remedies for Emission problems include:
Reduce the current level
- Reduce peak level
- Slow down rise time, increase fall time
- Reduce pulse repetition rate
Reduce the loop area
- Reduce large clock land areas
- Pin assignments
- Reduce line lengths – I/O cable
Grounding
Shielding
Filtering
Ozgur Ozturk will be speaking on the "EU EMC Directive and Fundamentals of EMC," Thursday, December 6th at 2-3:15pm in the PCB Carolina show at North Carolina State University.