Regulatory

  • DESIGN FMEA

    We ensure risk is minimised through the design process by undertaking Design Failure Mode Effects Analysis, as part of the development process.

  • MEDICAL DEVICE STANDARDS

    We ensure your products meet the required standards. For example, a sound knowledge of EN BS 60601 for medical device development is essential.

  • MEDICAL DEVICE SYMBOLS

    We ensure the relevant symbols are displayed on your medical device. These will either be engraved on the plastic moulding or on a printed label.

  • REGULATORY PACKAGING LABEL

    We can design your product label, ensuring the required information, such as medical device symbols and expiry dates are clearly shown

"We ensure your product meets the required standards"

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.


Regulatory Associate

We work closely with Meddiquest Limited, a specialist regulatory affairs consultancy, ensure all your regulatory requirements are met when developing products.

MEDDIQUEST LIMITED - Regulatory Affairs Consultancy
Meddiquest services the Medical, Scientific and BioTech sectors, and has in-depth knowledge of the medical regulatory requirements for US, European and other markets.


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.

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