A look at these gigantic figures perhaps gives some perspective of the importance of document management for the medical device industry: The US total market for medical devices is valued at over $110 billion annually. It makes up nearly two fifths of the global market, and is expected to grow by over 20 percent by 2016.
While many global players sell into the American market, the over 6500 American medical device companies too, on their part, sell in the US and other markets.
It goes without saying that a market whose products are often complex and play a critical role in sustaining life for patients has to be highly regulated. For products sold in the American market, irrespective of whether they are manufactured domestically or overseas, a slew of regulations exist for a number of activities. Document management for the medical device industry is one of the core areas for which the FDA has regulations.
FDA and other regulations for document management for medical device industryThe FDA and other regulatory bodies have regulations and standards for GxP processes in the medical device industry. These include:
- Quality System Regulation (QSR), which is outlined in 21 CFR Part 820, Current Good Manufacturing Practices (CGMP)
- 21 CFR Part 11
- ISO 13485, which relates to Quality Management System Requirements for medical devices
- ISO 14971
- Relevant sections of SOX, and
- ISO 9000 standards.
- It should help companies achieve regulatory compliance with required regulatory bodies and standards such as FDA, ISO and other regulations.
- It should do this by automating and managing GxP processes in an efficient and cost-effective manner.
- Communication between the functions of the company should be quick and efficient, and should allow access by designated persons.
- Document management for medical device industry should be designed to ensure quality compliance and help companies enhance the performance of the GxP processes all through the product development lifecycle. The document management system for medical device industry should help companies have control over critical activities such as:
- Design Control
- Device history record
- Mechanism for receiving and addressing complaints
- A record of the corrective actions the company takes of these complaints
- Note of nonconformances
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