Of all the regulatory regimes imposed throughout the world, the medical industry is one of the most regulated, and for good reason.
We need to know that the medical product is going to function as intended but more importantly provides the therapeutic benefit that it was designed to achieve – and not just the first product that comes off the production line but every single product.
Consequently medical regulatory requirements are written around all stages of being the product from concept to market, touching on your quality management system (QMS) specifically designed around medical needs, clinical and user trials to validation of the various aspects of the product itself.
Our regulatory affairs team incorporates a number of Engaged Experts that have clinical expertise and who have performed regulatory affairs roles in other organizations making them ideally suited to providing the guidance and advice needed to get your product through the regulatory requirements as quickly and efficiently as possible.
Our regulatory affairs services include:
- Advice on ‘risk management’ and ISO 14971
- Medical Quality Systems as per ISO 13485
- Software validation
- Usability assessments (including setting up of user group trials)
- Advice on Technical Files and compilation
- Applications to regulatory authorities including (EU Notified Bodies and FDA using the 510k route)
- Training on the regulations and routes to compliance