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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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Event Highlights Medical Device Regulations and Standardization Processes

Last month the Standards Alliance…

Last month the Standards Alliance teamed up with the National Institute of Quality and the ASTM Latin America Office for phase two of the Peru Workshop on Medical Devices Regulations and Standards: Policy and Technical Aspects in Lima, Peru.

The Standards Alliance is a public-private partnership between the American National Standards Institute and the U.S. Agency for International Development, and is focused on implementing of the WTO TBT Agreement in developing countries.

The event—held on January 24 and 25—was a follow-up to the first medical devices workshop held in November 2015 and focused on the implementation of medical devices quality management systems, quality control, and technical training on biological test methods.

More than 55 Peruvian participants representing the private and public sector attended the workshop. Representatives who provided the U.S. perspective included Dr. Terry Woods from the U.S. Food and Drug Administration, Dr. Spiro J. Megremis from the American Dental Association, Brian Berg from Boston Scientific, Dawn A. Lissy from Empirical Technologies, Stephen Spiegelberg from Cambridge Polymer Group, and ANSI International Policy Manager Jessica Roop.

The National Institute of Quality, Medicines, Supplies and Drugs, the Ministry of Foreign Trade and Tourism, National Institute of Health, and Peru Compras provided Peruvian viewpoints and feedback.

The workshop addressed key topics including:

  • Medical device regulations, standards, and conformity assessments in the United States and Peru with a focus on eliminating unnecessary barriers to trade.
  • Best practices in forging regulations and the use of standards for medical technology products.
  • Health and safety issues including level of risk classifications for medical devices and the effectiveness of standards in supporting these objectives.
  • Technical standards in public purchases and the challenges of medical device quality control.
  • ASTM International’s standardization processes, technical committees and material test methods for assessing and evaluating the performance of orthopedic and cardiovascular devices and test methods for analytical testing and assessing device cleanliness.
  • Inter-laboratory testing and the evolution of dentistry standards.

Click here to view the presentations from the workshop.

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