What general medical devices cover?
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:
Non-active, soft-tissue implanted medical devices
Abdominal wall and hernia repair devices; gastrointestinal / bariatric implants; neurological implants; reconstructive soft tissue implants; renal implants; lung 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, channeling and removal of substances.
MDR Annex XVI devices
Devices without an intended medical purpose as referred to in Regulation (EU) 2017/745 Article 1(2). Devices include contact lenses or other items intended to be introduced into or onto the eye; implants for the purpose of modifying the anatomy or fixation of body parts such as breast implants (excluding tattooing products and piercings), substances intended for facial or other dermal / mucous membrane fillings such as dermal fillers (excluding tattooing products); equipment for liposuction, lipolysis or lipoplasty.
Where products require additional expertise, we collaborate with our in-house clinicians and other technical teams.
