Regulatory Advice

We can provide guidance on meeting current and planned regulatory requirements relevant to your product. This can include advice on meeting requirements in markets throughout the world.

QCS can also develop relevant documentation and evidence that is required to support any application you may be making to enter a new market.

The process involved in designing and developing medical devices benefits from having controls in place to ensure the device meets statutory and regulatory requirements. It can be a very costly and time intensive to think about regulatory strategy once your product has been developed. Often there are additional regulatory requirements for different territories and having a clear understanding of these can drastically reduce the time to market for your device.

Robust risk reduction methodologies are at the centre of these design and development processes.

At QCS, we have consultants with experience in all phases of the product development life-cycle, so whether you are developing new products or are continually improving your existing products to keep up with ever more stringent regulatory requirements, QCS can provide the expertise you require with:

  • Device classification
  • Regulatory compliance pathway
  • Risk based product development to ISO 14971
  • The validation of developed prototypes (including the requirements for clinical evaluation and investigation)
  • New regulatory requirements (including the new ISO 13485:2016 and the proposed new European Regulations)
  • Vigilance requirements

GET IN TOUCH WITH US

Call us to discuss your needs and to have someone visit to prepare a quotation.
01236 734447

In Europe, legislation regarding Medical Devices is changing. The three existing medical device directives will be condensed into the ‘Medical Device Regulations’. There are also expected to be further additional hurdles related to verifying that devices meet all relevant legal requirements.

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