BSI Group - Meet the world with confidence

BSI Medical Devices: Meet the world with confidence

As a medical device manufacturer, there are a number of regulatory and quality requirements you must meet before you can sell your devices on the international market. In many cases, verification of your compliance must be completed by a third party assessor, or Certification Body. BSI is an established Certification Body for many market access schemes, including the leading Medical Devices Notified Body for CE marking. It is essential that your Certification Body has the capability and expertise to support you with robust product and system certification reviews, to ensure patient and user safety.

The BSI Medical Devices Mission

Our mission is to ensure patient safety while supporting timely access to global medical device technology. We strive to set the global standard in thorough, responsive, predictable conformity assessments, evaluations and certifications.

Through the passion and expertise of our people, BSI has become a leader in medical devices market access, delivering robust product and system certification that stands up to scrutiny and delivers confidence. We assess manufacturers for conformity to market access requirements as:

  • The world-leading full-scope Notified Body for CE marking.
  • A UKAS-accredited ISO 13485 Certification Body.
  • A recognised Auditing Organization under MDSAP.
  • A recognised Conformity Assessment Body and Certification Body in markets including Japan, Malaysia and Taiwan.

We offer truly global solutions that ensure patients have access to safe and effective devices.

For more than 100 years, BSI's expertise has provided an assurance of safety and quality to manufacturers. We now operate in over 180 countries, and our team of specialists is based around the world, with a combined experience in excess of 2,800 years.

With increasing scrutiny of medical devices and a changing regulatory landscape, it's essential to ensure that your product meets all regulatory and quality requirements before launch. It is critical to work with a leader that understands the industry and has the experience to review and confirm the product's readiness for market - efficiently, reliably and promptly. Talk to BSI today and learn more about market access with our certification services, training and product testing through our strong alliance partner.

Visit bsigroup.com/medical to start your journey.

Get more information about CE marking with BSI, at www.bsigroup.com/en-GB/medical-devices/our-services/ce-marking.

Learn more about QMS certification with BSI, at www.bsigroup.com/en-GB/medical-devices/our-services/iso-13485.

Visit our MDSAP webpage to learn more about the programme, at www.bsigroup.com/en-GB/medical-devices/our-services/Medical-Device-Single-Audit-Program.

View our full medical devices training portfolio, at www.bsigroup.com/en-GB/medical-devices/training.

Products and Services

Contact Details

BSI Group
389 Chiswick High Road
Chiswick
London
W4 4AL
United Kingdom
Tel: +44 (0)345 080 9000
Email: [email protected]
URL: www.bsigroup.com/en-GB/medical-devices/

Medical Device Regulation: The medical devices industry has been anticipating the finalisation of new regulations for some time. Final versions of the European Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR) have now been published.
The Medical Device Single Audit Program (MDSAP) allows a single audit of a medical device manufacturer's QMS which satisfies the requirements of multiple regulatory jurisdictions.
CE marking approval and certification: A medical device can only be sold in Europe with a CE mark. By placing the CE mark on a product, the manufacturer declares that their product complies with all applicable European Medical Device Directives.
The ISO 13485 standard is an effective solution to meet the comprehensive requirements for a Medical Devices QMS. Find out more about ISO 13485 certification with BSI.
Why train with BSI? We offer one of the widest ranges of standards-related training available from meeting medical devices regulation to managing your energy effectively.
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