Unrivalled expertise from an EU Notified Body and UK Approved Body

BSI Medical Devices has a team of technical specialists with expertise across all types of medical devices. These are just some of the devices the General team supports:

Implanted medical devices
Abdominal wall and hernia repair devices; gastrointestinal implants; neurological implants; reconstructive soft tissue implants; renal implants; embolization beads; hemostatic agents and tissue adhesives

Wound and skin care medical devices
Bandages; barrier creams and gels; sutures and clamps; wound cleansing solutions; advanced wound dressings; surgical closure devices

Ophthalmic medical devices
Contact lens solutions; contact lenses; intraocular lenses; ophthalmic diagnostic devices; ophthalmic prosthetic devices; ophthalmic stents; ophthalmic surgical instruments

Medical devices for infusion and transfusion
Blood bags; blood tubing; dialysis solutions, concentrates, powders, and dialysates; infusion sets; transfusion sets

Other medical devices
Devices for anesthesia, emergency and intensive case; disinfecting solutions; general surgical instrumentation; gloves; ingestible devices; condoms and lubricants, intrauterine devices; devices utilizing nanomaterials; devices for administration, channelling and removal of substances

Where products require additional expertise, we collaborate with our in-house clinicians and other technical teams.

Our General team of highly trained technical specialists are product experts who work with device manufacturers and understand the specifics of complex medical devices.

The team has an average of 20 years’ industry and regulatory experience, and we are able to provide conformity assessments under the EU MDR and UK MDR (2002).

The challenges presented to manufacturers by the introduction of the EU MDR and UK MDR 2002 are significant, particularly for those manufacturing implantable devices. Our experienced General team provides the guidance and resources manufacturers need to support them on their journey to bringing their product onto the market. For CE marking, we have developed MDR Best Practices Guidelines to assist with this.