BSI Medical Devices provide comprehensive regulatory and market access services so medical device manufacturers can stay compliant and sell into global markets.
Medical Device Regulation (MDR) 2017/745 FurtherIndustry and Regulatory Guidanceis also available. BSI the Netherlands is a leading Notified Body (2797) achieving full-scope designation under MDR and IVDR. We are also a full-scope UK Approved Body (0086) assessing medical devices and IVDs against...
BSI is a leading global organization with technical expertise and experience from a notified body for medical device technologies and products worldwide.
Our priority is, and always has, been patient safety, and at this current moment, we are continuing to work within the relevant legal and regulatory frameworks to do everything possible to put the safety of patients, our clients and own people first. ...
Medical device firms must haveISO 13485 certificationfor their quality management systems. ISO 13485 certification is required for companies that design, manufacture, install, and service medical equipment and related services. When performing compliance evaluations, regulatory bodies and certifying organization...
It also provides an overview of medical devices and IVDs regulatory framework, as well as BSI Regulatory Services offer for Quality Management System (QMS) and product certification (CE and UKCA).Discover what you need to know about Notified Body and UK Approved Body certification services and ...
Placing your device on the market You must ensure that your device meets the relevant regulatory requirements before being placed to the market. It is critical to work with an EU Notified Body or UK Approved Body that understands the industry and has the experience to review and confirm your ...
A team of over 1000 people and technical experts specialized in encompassing the full range of medical devices and regulatory certification services Full-scope Notified Body and Approved Body providing conformity assessments under the applicable European and UK legislation Single technical point of contact...
We are also a Conformity Assessment Body for EN ISO 17021-1 as accredited by the Dutch Accreditation Council & UK Accreditation Service. We offer: Preparation support Ensuring product development meets regulatory requirements is essential. At BSI, we provide training to support you through the applic...
European Database on Medical Devices The European Database on Medical Devices (EUDAMED) is the IT system developed by the European Commission as an integral part of MDR and IVDR implementation. Find our more > BSI Regulatory Services (Medical Devices) Certification Business Policy ...