We can help define an efficient strategy for compliance to international regulations to assist in the smooth launch of your product. This includes support and guidance for gaining CE marking or conformity to associated international standards.
We can support you in the compilation of clinical evaluations including the required risk benefit analysis and associated risk management report required for releasing a medical device to market.
Product launches are exciting and also resource hungry activities. We can help support during this often challenging time. In particular we have skills in the following areas
Quality management of suppliers
Issue resolution whilst maintaining supply
Expansion to meet demand
We work with Design Controls ISO 13485:2016, Risk Management ISO 14971, Usability ISO 62366 and cGMP (Pharmaceutical Good Manufacturing Practice)