3. Maintain compliance to ISO 14644, ISO 13485, and FDA CFR 820, 211
With a 10 year medical device background with heavy emphasis on Regulatory and Quality, we understand that compliance to ISO 14644, ISO 13485, and Current Good Manufacturing Practices (cGMP) as it relates to cleanrooms, quality systems, and facilities can be difficult. Help alleviate the burden on operations and quality staff in evaluating existing and expanding space requirements. Ensure building is capable of supporting core functions and maintaining compliance for continued success. Help avoid ISO noncompliance, FDA Form 483, or FDA Warning Letter due to facility issues.