I want to develop a medical device. What steps should I take to optimise the design of my new product?
ISO 13485:2016 specifies that the agency shall establish documented procedures for the design and development. But what does this really mean?
With nex’design, you are accompanied at all stages of the design of your medical device
- Training in design know-how;
- Define requirements: developing a regulatory strategy plan and planning your project;
- Control your project and animation of progress meetings;
- Draft design input data;
- Develop your prototype and animation of design reviews;
- Verify and validate the design of your product;
- Edit the technical file and its submission to the notified bodies;
- Transfer your product into production;
- Post-market surveillance of the product and controll changes that will be made over time.
Benefits for your business
- Save a considerably amount of time on the design steps for strong optimisation of the time to market;
- Completion of all steps in a logical and chronological order;
- Insurance to comply with regulatory requirements applicable to the MD sector.
What are the risks of a poorly structured approach?
- Loss of time at the design stages;
- If you are not in compliance with regulatory requirements, you can lose the compliance of your products with the regulations and therefore have your products suspended or withdrawn from the market.