This Medical Device Regulatory training will review changes to regulations including the European Union Medical Device Directive and also discuss changes to international standards, which will also impact the medical device industry.
Why should you Attend:
Regulatory changes are coming to the medical device industry from the US FDA, from the EU and other country’s' regulatory agencies. In the US FDA has been forced to change by the US Congress and the new administration, and is becoming more aggressive in enforcing its current regulations. Additionally in the US there is uncertainty on reimbursement for devices. The EU is making major changes to the Medical Device Directive which is its regulatory scheme for devices. International Standards are being revised and updated, such as the IEC 60601 family, causing additional pressures on the industry.
This presentation will discuss changes to the regulatory environment for the medical device industry. We will discuss coming changes in regulatory enforcement by agencies such as the US FDA. These changes also will negatively impact the approval of new devices. The presentation will review changes to regulations including the European Union Medical Device Directive. We will also discuss changes to international standards, which will also impact the medical device industry. All of these issues are coming at a time of economic strain and uncertainty for device manufacturers.
Areas Covered in the seminar:
- Changes to the FDA organization with the new administration.
- Changes in FDA enforcement topics.
- New FDA Warning Letter Initiative.
- Revisions to the European Union Medical Device Directive taking effect in 2010.
- Impact of changes to IEC 60601 taking effect in 2012.
- Updating of device standards to include Risk Management.
- Impact of the Global Harmonization Task Force to the regulatory environment.
Who will benefit:
- Regulatory Affairs personnel
- Regulatory Affairs Managers
- Qualtiy Managers
- Quality Assurance Engineers
- Design Managers
- Process Engineering
- Internal Quality System Auditors
Instructor Profile:
Edwin L. Bills, is the Principal Consultant for Bilanx Consulting LLC, a consulting firm that provides assistance to medical device companies in compliance with US FDA regulations, in development of Quality Management Systems and Risk Management processes. Edwin has over 20 years experience in the medical device industry and has participated in development of industry standards, including ISO 14971. In his consulting role he has assisted companies in Warning Letter responses. Edwin has also participated in training both company and FDA personnel in the Quality System Regulation and Product Risk Management.
