During the years, we have been working with many different quality management systems at many different companies. Having seen many quality management systems, we have acquired the knowledge of what works, and what sometimes may not so well.
By using our knowledge and experience, we can assist you in designing and tuning your existing quality management system, both cost effectively, and in accordance with requirements in the EU- and FDA GMPs - 21 CFR 210, 211, or 820 (Quality System Regulations), ISO 9001 and ISO 13485.