Services

Services

We offer a range of comprehensive and proven regulatory services providing you with efficient pathways to bring your product to market

We offer a range of comprehensive and proven regulatory services providing you with efficient pathways to bring your product to market
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Medical Devices services
Medical Devices services
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Proven regulatory services for medical device manufacturers

The benefits of having experienced, professional and well qualified technical specialists cannot be overstated in the complex and ever-changing medical device industry. BSI Medical Devices has a team of over 750 colleagues; within that team are our technical experts with experience encompassing the full range of medical devices and management system standards.

Clients work with us because we understand the challenges medical device manufacturers face in bringing compliant products to market efficiently and safely. We offer a range of flexible product review services providing you with efficient pathways to bring your product to market.

We are a global organization, trusted and recognized around the world. BSI The Netherlands (2797) is a leading Notified Body; we review medical devices to ensure that they conform to the requirements of the European Directives and Regulations. BSI UK (0086) is a UK Approved Body able to provide conformity assessments under the new UKCA scheme.

Our comprehensive review process combined with our world leading experience as a Notified Body will ensure that your conformity assessment process is both efficient and robust.

Explore the services we provide

How can BSI support your product launch?

Be prepared

In the competitive medical device marketplace, ensuring that product development meets all regulatory requirements is essential. We provide guidance and training to support you through the application process.

Worldwide access

We offer a wide range of proven regulatory and quality management programs that work together for full international compliance. Our Quality Management System (QMS) solutions include ISO 13485, ISO 9001, ISO 14001 and many more.

We are a recognized Certification Body in Hong Kong, Japan, Malaysia, Singapore and Taiwan, and a recognized MDSAP Auditing Organization for all participating Regulatory Authorities.

Seamless transfer to BSI

We can offer a seamless service with comprehensive support and the absolute minimum level of disruption.

Certification support and additional services

We offer continual support throughout the certification process and beyond; we also offer:

  • access to more than 34,000 standards and related products, as well as online guidance documents
  • expert training delivered online or face-to-face, either inhouse or through our public training courses
  • regulatory updates and a newsletter service focusing on industry changes, helping you to plan for the future
  • webinars delivered by our experts on complex regulatory issues
  • comprehensive whitepapers providing the latest insights on key industry topics
Find out more about the notified body >

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