Healthcare and medical device standards

Healthcare and medical device standards

The healthcare sector is highly regulated with standards, rules and legislation. To help manufacturers sift through the minefield of regulations, we can help with best practice guidelines, standards, supporting documentation and seminars.

We bring together industry and Government stakeholders to produce standards that maximise the safe and effective provision of healthcare throughout the UK. This is achieved by developing standards in support of legislation for medical device products, and providing guidance on the risk and quality management within the manufacturing process. Standards are also developed to describe best practice in healthcare service provision, and to support emerging industries such as eHealth, nanotechnology and regenerative medicine.

ISO 13485 Expert commentary


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    Current Standards for Healthcare & Medical Devices

    Key Standards

    BS EN 285:2015 BS EN 60601-1-11:2015
    BS EN 285:2015
    BS EN 60601-1-11:2015
    Sterilization. Steam sterilizers. Large sterilizers Medical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
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    ISO 13485

    The world's most popular standard for medical devices quality management

    Take the smart route to manage medical device compliance