Manufacturing & Production

We support clients in managing manufacturing operations, ensuring that your device is produced according to the highest standards of quality, with the flexibility of outsourcing manufacturing to contract manufacturers.

• Contract Manufacturing: We facilitate partnerships with reliable contract manufacturers who meet your specifications and regulatory standards for medical device production.
Standards: ISO 13485 (Quality Management Systems for Manufacturing)

• Contract Packaging & Labelling: We oversee contract packaging and labeling operations to ensure full compliance with regulatory requirements for medical device packaging and labelling.
Standards: ISO 13485 (Labelling), ISO 11607 (Packaging)

• Turnkey Projects: We manage complete turnkey solutions, covering all aspects from design to final production and market launch for medical device projects.
Standards: ISO 13485, EU MDR 2017/745, 21 CFR 820