Quality management and medical device certification
Cisteo MEDICAL can assist you in all your regulatory and normative procedures, drafting medical device certification applications and implementing your quality management system to obtain certification. We offer assistance for all medical device classes, which includes dealing with your notified body.
Regulatory and normative assistance
Our team can assist you in drafting and/or updating your regulatory files for European markets (EU Regulations 2017/745 and 2017/746) and also US, Canadian, Brazilian markets, etc. We can draft or update your certification documents (CE, FDA, RIM, etc.) in part or in full, and also proofread them and offer advice on drafting. We can also help you with specific issues such as biocompatibility, risk management, standards applicable to your medical device, and so on.
We can help to create and implement your quality management system at your company/organisation in compliance with ISO 13485 and/or 21 CFR part 820 and/or RIM.