Regulatory

Regulatory services at Gm Design Development


Ensuring the regulatory requirements form part of the product specification is critical when developing medical devices

Gm Design Development understands it is crucial to understand the regulatory requirements when developing healthcare and medical products. We have over 15 years knowledge of medical standards, and know how critical it is to fully understand them at the start of any development project. It ensures your product will meet all the requirements, as well as saving considerable re-development costs.


DFMEA
We ensure risk is minimised through the design process by undertaking Design Failure Mode Effects Analysis, often organising the whole team to take part. Scores are calculated and rectifications made to improve the scoring to a satisfactory level.

Regulatory advice and testing
As part of the development process, we undertake early R&D and testing to prove key aspects of the design.

ISO standards
We ensure the design of your product or device meets the required standards, such as EN 60601 for electronic medical products. Ensuring the relevant standards are incorporated into the specification at the start of the development is critical.

510K/FDA
We can help with ensuring meets the requirements of 510K if your product is to be sold in the US. A regulatory specialist will assist you with the requirements and deliverables needed.