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.
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:
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.
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.
