A German manufacturer of medical devices is looking for a contract manufacturer for their specific sterile single-use syringe. The partner sought should have expertise in manufacturing of medical devices and should already work according ISO 13485 (certificate) and (ideally) MDR (medical device regulation). As the company will be legal manufacturer according to MDR, the partner needs to be prepared to share the technical files according to MDR requirements. A manufacturing agreement is sought.
The German company is a manufacturer of medical devices and currently transferring to MDR. Since 2003, the company is in longstanding business relationships with multiple suppliers. For one of its products, an active medical device, specific sterile single-use disposable components in special dimensions are needed. The company therefore seeks a contract manufacturer who is capable of producing a sterile single-use syringe with special custom-made dimensions. They are looking for a contract manufacturer with expertise in manufacturing of medical devices for a manufacturing agreement. They prefer companies from Europe including Turkey. The partrner sought should already work according to ISO 13485 - certificate is a must - and (ideally) MDR. Technical drawings including in-detail dimensions will of course be supplied by the German company.
Type (e.g. company, R&D institution…), field of industry and Role of Partner Sought:
The company sought should have expertise in manufacturing of medical devices and should already work according ISO 13485 and (ideally) MDR. As the company will be legal manufacturer according to MDR, the partner needs to be prepared to share the technical files according to MDR requirements. Companies from Europe including Turkey are preferred.
Technical Specification or Expertise Sought:
The company is looking for a partner with expertise for injection moulding for single-use syringes. The challenges are - client-specific, customized dimensions: the components must fit on a centrifuge - the partner sought must be ISO 13485 certified and - must be experienced in the manufacturing of client specific medical devices because he needs to be prepared to share the technical files according to MDR requirements
Stage of Development:
Already on the market