You have successfully obtained the ISO certification or set up a 21 CFR 820 quality system.
You are wanting to maintain your quality management system and adapt it to new markets.
We can assist you in :
• Maintaining your ISO 13485 or 21 CFR 820 Quality Management System
• Realizing the internal audits of your processes
• Validating or revalidating your processes
• Validating or revalidating software
• Acting as quality manager for you, if you don't have one in-house.
Most young companies obtain ISO certification on the first attempt.
Things can get worse with the quality management system as companies have to dedicate resources to commercial efforts to get expected revenue.
We can help you in this critical phase where quality assurance constraints shouldn't be put aside.