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Workshop to Address Medical Device Regulatory Changes

TÜV SÜD will host a…

TÜV SÜD will host a workshop in March to help manufacturers understand the changing medical device regulatory landscape as a result of the upcoming overhaul of the European Union’s Medical Device Regulation and Approval Process (MDR).

The 2017 MDR Workshop will take place on March 13 at the Kimpton Palomar Hotel in San Diego, California. It will be led by Dr. Bassil Akra, TÜV SÜD’s global director of clinical centers of excellence,

Dr. Akra has a distinguished career in research and development, quality management, and regulatory affairs. He is deeply involved with the development of the EU’s guidance and standards in his capacity as a member of the working group on clinical investigation and evaluation.

Other speakers at the workshop will include Dr. Matthias Fink, Dr. Gerold Labek, and Dr. Yuan Li of TÜV SÜD.

The focus of the workshop will be the regulatory requirements surrounding complex Class III medical devices, such as orthopedics, implants, and those used in contact with the spinal column. Devices previously certified on an equivalence basis and without a significant amount of clinical data may not be certified under the new rules.

Overall, the MDR calls for increased standards for clinical evidence, more intensive documentation, an expansion of the scope of covered devices, and the implementation of unique device identification codes for better tracking of potential defects.

Registration for the workshop will open at 1:30 p.m. PST and the workshop will run from 2:00 p.m. to 6:00 p.m. A group reception and networking buffet will follow. Click here for more information on the workshop.

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TÜV SÜD Acquires Advanced Compliance Solutions

Provider of testing, auditing, inspection…

Provider of testing, auditing, inspection and certification, training, and consultancy services, TÜV SÜD, has acquired the assets of Advanced Compliance Solutions Inc. (ACS).

ACS was co-founded in 2001 by brothers Scott and Michael Proffitt and partner Sam Wismer. Together they set out to reduce compliance-testing burdens for manufacturers and streamline the approval process. By providing flexible solutions, ACS maintain a strong focus on customer service, making them an ideal partner for TÜV SÜD.

All five ACS testing facilities in Georgia, Florida, and North Carolina are now part of the TÜV SÜD America organization. The combined organization now serves as a premier provider of testing and certification services for EMC, wireless, product safety, Energy Star, and other quality and performance evaluations.

This union of people, equipment and locations greatly expands the reach and capabilities of TÜV SÜD in the southeast United States.

TÜV SÜD Director of Sales and Business Development Doug Hughes said they are excited to welcome ACS to the TÜV SÜD family.

“They have been one of the most respected and successful service providers in the industry for more than 15 years,” Hughes said. “The integration of ACS into TÜV SÜD demonstrates our continued dedication to growth and excellence in the United States. In addition to anchoring our safety certification and EMC capabilities in the Southeast, it greatly expands our wireless testing and certification portfolio.”

ACS Co-founder and President Scott Proffitt said “if you surround yourself with good people who are the best at what they do, you’ll have a team that is ready to tackle any challenge and overcome any obstacle.

“Our long relationship as a partner lab has strengthened the synergies between our team and the like-minded staff at TÜV SÜD,” Proffitt said.

The post TÜV SÜD Acquires Advanced Compliance Solutions appeared first on The Auditor.