To place a medical device on the market, manufacturers shall apply the applicable conformity assessment procedures on their devices. The assessment must be supported by technical documentation revealing basic processes associated with the product: development, production, quality, tests etc.

Regulatory agencies' of different countries have different standards for technical documentation. You should consider all local requirements while placing your medical device on different markets.

Technical documentation is an integral part of the manufacturer's quality management system. It should conform to manufacturer's internal policies and procedures.

We know the standards that apply to technical files in different countries and have experience creating technical documentation which complies with provisions of different regulatory agencies. We can create technical files for your products or make your existing documentation compliant with regulatory requirements of different countries.