Combination Products: Regulatory Challenges and Successful by Smita Gopalaswamy

By Smita Gopalaswamy

The sector of blend product improvement is so new that only a few guides, together with FDA files, can be found. this article offers an outline of the method from begin to end, entire with proper definitions, after which indicates tips to identify a layout and improvement plan. It offers an summary of FDA and different regulatory expectancies and covers source standards, production, pitfalls, post-launch compliance necessities, and corporation audits and demanding situations. The ebook provides sensible guidance on tips to increase mix items effectively and the way to enforce those items into the industry effectively and in a well timed demeanour.

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Additional info for Combination Products: Regulatory Challenges and Successful Product Development

Example text

We introduced the term VOC (voice of the customer) earlier. This term is used largely by Six Sigma professionals, but it is applicable in combination product development as well. VOC is an approach to effectively deal with the variability mentioned in the previous paragraph. Combination product reliability planning is totally dependent on VOC, and it starts this early in the new product development (NPD) process. The VOC approach also lays the foundation to define the market segmentation or development of a marketing strategy.

The CA in one member state does not have jurisdiction in any other member state, but he or she does exchange information and try to reach common positions. indd 20 07/03/2008 09:50:38 Chapter two: Overview of combination products 21 his or her own member state. A CA is not obliged to appoint a notified body. However, he or she can appoint as many as apply that meet the criteria, and there is no limit. A few small countries do not have any notified bodies. 2. , independent testing house, laboratory, or product certifier) authorized by the relevant member state’s competent authority to perform the conformity assessment tasks specified in the Medical Devices Directive.

Competent authority (CA): A body with authority to act on behalf of the government of the member state to ensure that the requirements of the Medical Devices Directive are transposed into national law and applied. The government of each member state is required to appoint a CA responsible for medical devices. The CA reports to the minister of health in the member state. The CA in one member state does not have jurisdiction in any other member state, but he or she does exchange information and try to reach common positions.

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