Contract & OEM Manufacturing
QMEDICS contract manufacturing services consistently deliver quality assured products that meet tight specifications. Our extensive expertise and knowledge of international requirements helps to assure your product will be compliant with the harmonised standards and regional requirements. Our goal is to deliver customized products and personalized services, while providing flexibility and guidance to help our customers to achieve their goals in a timely, efficient, and cost-effective manner. We supply custom tailored products, solutions and technologies.
QMEDICS OEM and contracted manufacturing is a trusted partner with in-house stent and balloon development, manufacturing and clinical/regulatory capabilities.
In R&D there‘s a “R” and there‘s a “D”, and the two are completely separate activities. Research is all about discovering new things; we research an idea or a need, and then switch to development mode. Development is taking known ideas and using them to build products. The transformation of an idea to logic components or into devices is the bulk of an engineers work.
The R&D engineers can assist our customers in developing and improving their products, thus considerably contributing to the products cost reduction.
Our in-house engineers are able to support any special project with customised solutions to each technological problem, thanks to our know-how and relationship with a large network of technical partners.
The core competence of the R&D team is:
- Designing and/or specifying new products, test processes, equipment and specifying raw materials to ensure the concepts and/or prototypes meet their requirements.
- Provide guidance in the development of prototypes, verification/validation and product specification, including material specifications, assembly drawings and manufacturing documentation.
- Comply with appropriate regulatory requirements and associated quality systems.
Testing mechanical performance as balloon burst and compliance tests, tensile strength, track test in tortuous path model, radial force testing etc. is core competence of our development lab. Support in defining product design specifications as well as design verification and validation to ensure regulatory compliance, report generation, test method development, shelf-life testing, climatic chambers storage, sterilisation and packaging.
Laser cutting and welding
QMEDICS excercises a wide range of processes within the field of stent processing. Our core technologies cover tube cutting, grinding, laser welding, sandblasting, heat treatment and mechanical as well as electrochemical surface finishing. We provide several laser cutting technologies e.g. fiber laser and/or femtosecond laser.
Blow molding, Plastic welding
QMEDICS maintains two continuously controlled ISO class 8 production floors. Within this controlled environment we have the capability to manufacture medical devices from diameter 0.2 mm up to 5 mm. Our core technologies cover blow molding, cutting, welding, gluing, clean-room packaging, sterilisation and labeling.
QMEDICS provides a bright knowledge in mechanical as well as electrochemical surface finishing. Meticulous surface finishing and polishing to remove imperfections and improve fracture resistance. Each implant must pass rigorous cleaning and testing prior to product release.
Contracted Sterilisation EtO
QMEDICS offers a fully automated low temperature EtO-Sterilisation process. The fact, that all process-relevant parameters are continuously monitored and saved independently from the control unit, is allowing for parametric product release without bio-indicators or sterility testing.
Regulatory & Clinical Affairs
The regulatory process, is a dynamic, evolving landscape. Effective Regulatory strategies are critical to the successful pathway for product approval and commercialization of your product. In addition, the increasing globalization of clinical trials requires the understanding and compliance to multiple and often diverse regulatory and operating standards. Knowing which regulatory agency to contact is not enough.
Within this constantly changing and globally diverse regulatory environment, the need for experienced Regulatory staff is critical to the success of your product development.
Our RCA department helps you with the increasingly complex global regulatory requirements. Navigating and executing mandatory reporting requirements is standard work but not always easy we can help. Notifications/Registrations and consultancy services for medical devices we can provide. Our departments and business processes, including data processing and report writing, comply with current GCP and GLP standards.
Referenced Standards & Directives:
ISO 13485: 2016 Quality Systems – Medical Devices
ISO 9001: 2015 Quality Systems – Requirements
MDD 93/42/EEC Medical Devices Directive
MDR Medical Device Regulation
FDA 21 CFR Part 820 Quality Systems Regulation
SOR/98-282 Food and Drugs Act
Decree of the State Council of the People’s Republic of China No. 650
MHLW Ministerial Ordinance No. 169