2011 was quite a year for publishing proposed major changes to the regulatory framework for medical device and diagnostics manufacturers. It is likely that more certainty will be introduced during 2012 as to what the changes will be and how they will affect MD&D companies. The major topics include the 510K process in the US, the planned recast of the Medical Device Directives in the EU, potential changes to the informed consent process for sample collection in the US, planned changes to the monitoring guidance in the US, and the changes to the ISO 14155 standard issued in 2011.

In this audio conference, our speaker reviews the changes or proposed changes to the regulatory framework, discusses the implications for MD&D companies, and describe how best to plan for future changes. The presentation also provides pointers on when the changes currently in draft form are likely to be implemented. This audio conference is intended to summarize the 2011 regulatory landscape for MD&D companies, and help them prepare for 2012 and beyond.

This audio conference covers:

• The proposed changes to the 510K process in the US
• The planned recast of the medical device directives in the EU
• The impact of planned changes to the Common Rule in the US
• The recently issued revised monitoring guidance in the US
• The issued revised ISO 14155 standard for GCP in medical device trials

About the speaker:

Dr. Helen Colquhoun is CEO of Pleiad Inc, a full-service clinical research organization, providing regulatory and clinical support to medical device and diagnostics companies. She has worked in the medical device and pharmaceutical industries for more than 23 years. She is a physician with a depth of experience in vigilance, pharmacovigilance, regulatory affairs, clinical study design and management, and product development planning. Her expertise covers North America and Europe. She is based in Cambridge, Massachusetts

Who should attend?

• Clinical Operations
• Regulatory Affairs
• Biometrics Staff