All our products, processes, and production sites live up to a high level of quality that is maintained professionally and efficiently through our quality management system.
All parts of the manufacturing process are certified and approved by regulatory agencies across the world.
This is your guarantee that the product lives up to the standards needed to ensure a high level of safety for your clients and product users.
When working with us, you will experience that procedures and instructions are key to the high quality of our products.
Our product quality kicks off in product development where we focus on reducing patient and product risks.
Our quality management continues in production with in-process controls and vision control systems supported by our highly skilled staff.
Input from post market surveillance is used for continued improvement in processes as well as products.
The safety of our patients is our highest priority and we carefully monitor complaint statistics related to usability.
We have proven experience in the licensing and registration of medical devices in accordance with international standards.
Depending on the product and requirement of the local health authorities, we can help bring your product to market.
Our extensive record of successful approvals obtained from major regulatory agencies across the world demonstrates the competences of our organization in licensing your product or supporting you in obtaining your own license regardless of Legal Manufacturer status.
Our Approvals and Certifications
• MDSAP certification, including US FDA, EU, Japan, Brazil, Australia, and Canada
• ISO 13485:2016 certification
• Selected standards and regulations:
o ISO 14971 Risk Management
o ISO 10993 Biological Evaluation
o ISO 14155 Clinical Evaluation
o IEC 62366 UE o REACH Regulation (EC)
o ISO 14644-1 Cleanrooms and Associated Controlled Environments o International Standards for statistics, medical tubings, needles, connectors, Unique Device Identifier (UDI) and labelling, packaging, sterilization, and shipment.
• MDR certification planned for 2020
Medical Hospital Devices
Our hospital medical devices are CE-marked and ready to be placed on the market, and we offer off-the-shelf quality products and well-established QA and RA setups.
Our medical films are ISO 9001 certified and environmentally approved meeting national and EC requirements. Our fully automated weighing system guarantees compliance with the formulation and a consistent compound quality.
Throughout production, the film is monitored by an in-line vision system as well as a computerized gauge control to ensure a uniform and flawless quality.
Furthermore, we are making off-line control of film thickness, color, heat shrinkage, curvature, and roughness or other customer specific film quality tests depending on end usage.
Want to Know More?
Please contact our hospital medical devices and medical film teams for specific information about approvals and certifications.