services | examples

Some of the products that TCM have designed and developed in partnership:

see below for examples

TCM can help you take your medical device idea make it work and get it sold.

We provide a complete service from product design through regulatory submission to production scale-up. In particular, we have specialist expertise in the design and development of orthopaedic bone cements and synthetic bone substitutes.

We have a wealth of practical knowledge in taking an idea all the way from paper to production. We will help you overcome regulatory and technical problems as well as provide you with management and marketing expertise to ensure that the product sells.

• Product design and submission for CE mark approval
• ISO 9001/46001 registered through Lloyds Register
• Bulk product manufacture
• Bulk product packaged, labelled and sterilised if required
• advice on ethylene oxide and gamma irradiation validation available
• own transport available for collection / delivery

TCM has a vast amount of experience in working in partnership with various companies and organisations to produce and develop medical devices and products.

Some of the products that we have worked on:

Bone Cement Products

Developed a Glass Ionomer cement to preproduction launch stage.

Developed a modified tricalcium phosphate synthetic bone extension material, having superior load bearing and porosity properties.

Developed two formulations of Non-antibiotic Bone Cement , having setting characteristics tailored for digital or gun insertion. These CE marked products have been selling in international markets for almost two years.

Developed an antibiotic Bone Cement and set up isolation technology for production. Advised on regulatory processes to prelaunch stage.

Other Medical Products

We took the Rowmed Cryoprobe (a device for treating skin lesions with cryotherapy without using liquid nitrogen) from prototype, through type testing and CE mark registration to preproduction stage. Scaled up to production and launched in July 1998.

Currently in the final stages of registration for CE mark of the Hemocool (a device for treating haemorrhoids).

We are in the early stages of launching a product based on Tea Tree oil for treating vaginal candidiasis.

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