Do you believe the world deserves excellence?
BSI (British Standards Institution) has over 81,000 clients in 180 countries, and is an organization whose standards inspire excellence across the globe. BSI Medical Devices Notified Body provides rigorous CE and ISO 13485 certification to manufacturers globally.
Our role as a Notified Body is to conduct a conformity assessment under the relevant EU Directives. The Notified Body conducts the conformity assessment against the relevant sections of the applicable Directive (MDD, AIMDD or IVDD). The conformity assessment usually involves an audit of the manufacturer’s quality system and depending upon the particular classification of the device, a review of the relevant technical documentation provided by the manufacturer in support of the safety and performance claims for the device.
The technical documentation is assessed against the essential requirements set out within the EU Directives and considers the relevant guidance set out by the EU.
The team apply their knowledge to 3rd party conformity assessment of all types of medical devices; active devices, active implantable devices, in vitro diagnostic devices, orthopaedic and dental devices, vascular devices, wound care devices and many others. The team has doubled in size over the past eight years, demonstrating the company’s desire to succeed and deliver world beating results. There are exciting opportunities for further growth of the Medical Devices team.
Who are our Technical Specialists?
Our technical specialists are the industry and product experts who work to review manufacturers’ technical documentation against the relevant requirements as part of a conformity assessment.
Our technical specialists are home based and enjoy flexibility in their role, with a variety of activities including documentation review, frequent client contact, liaison with global Regulatory Authorities, and international travel.
This fast paced role will allow you to develop your own knowledge in your area of expertise, as you remain on the forefront of innovation. Robust training will develop your knowledge of the applicable Regulations, leading to you autonomously managing a portfolio of products
Who are our 13485 Assessors/Auditors?
Our Assessors are the auditors who work to review manufacturers’ Quality Management Systems against the relevant requirements as part of a conformity assessment to medical devices regulations, directives and standards.
Our Assessors are home based and enjoy flexibility in their role, with a variety of activities including site visits, documentation review, frequent client contact, and international travel. This fast paced role will allow you to develop your knowledge in your area of expertise, as you drive continual improvement in the industry. Robust training will develop your knowledge of the applicable legislation, leading to you autonomously managing a portfolio of clients.