Contributing to the well being of mankind is divine and demands safe and effective products in the hands of the consumer. However, to stay competitive in such a profoundly changing industry requires ensuring robust devices and products. This is a challenge that has to be met by going beyond compliance to minimum regulatory standards. When it comes to healthcare, there are no limits.
Consumer confidence is the foremost goal.
Achieving this goal means setting high standards in quality. The standards of practice in Quality and Validation have been evolutionary though they seem at times to be more revolutionary. ISO 9001 along with FDA guidance documents are common examples. But the use of these documents alone can sometimes lead to vastly different interpretations that can result in needless or excessive activities. Help your company or project reach its goals by becoming a member of the American Society of Validation Engineers.