If you design, develop, produce, install or service any medical device you need to comply with the requirements set out in various European Directives. To help manufacturers sift through the minefield of regulations, BSI can help with best practice guidelines, standards, supporting documentation and seminars.
Essential services for medical device manufacturers, healthcare practitioners and users of healthcare information.
Standards & Publications
BSI publishes standards on a wide range of medical devices including dental equipment, neurosurgical implants, prosthetics, anaesthetic and respiratory equipment. Included in this collection are standards on the evaluation, validation and sterilization of medical devices and their use in the healthcare sector as well as a section on health informatics.
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Training & Conferences
We are one of the world’s leading providers of training, conferences, information and knowledge on standards, management systems, business improvement and regulatory approval.
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Assessment & Certification
BSI Product Services offer a variety of schemes for the world market, including: Quality Management Systems for Medical Devices (ISO 13485), CE marking, US FDA, CMDCAS Canada and Japan (PAL).
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We provide services that help manufacturers understand the requirements for placing compliant medical devices on markets throughout the world. We provide a wide range of support services including training, assessment and integrated management system solutions.
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Product Testing
BSI is uniquely positioned to interpret the global situation today and guide on the emerging requirements and regulations. We provide services that help manufacturers understand what they need to do to place compliant devices on markets throughout the world.
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