- An ISO 13485 registered contract manufacturer (CM) must regularly demonstrate existing infrastructure to encompass the traceability, risk assessment, and QMS required to support their customer’s regulatory compliance.
- A CM should have business systems and procedures in place for achieving and maintaining aggressive schedules for the manufacture of your particular medical device.
- A CM must have robust QA procedures, equipment, and tools in place to meet the rigorous technical quality specifications of the medical device industry.
Medical device and equipment manufacturers, seeking to outsource the manufacture of their product, must carefully consider many factors to ensure the selection of the appropriate contract manufacturer (CM). Of the variety of criteria to consider, among the most important are:
- The CM’s certification or qualifications
- A demonstrable capability to meet delivery deadlines and technical specifications
- The suitability of the supplier’s skill sets to the technical specifics of your product
Certifications for Contract Manufacturers
The term “medical device” is broad, and may include implantable devices, surgical instruments, wearable medical technology, diagnostic instruments, etc. The first step in evaluating a CM is to ascertain the qualifications and/or certifications they possess as it relates to producing your type of medical device.
Companies like Keller Technology Corporation – ISO 13485 registered – must regularly demonstrate existing infrastructure to encompass the traceability, risk assessment, and quality management systems required to support their customer’s regulatory compliance. Keller Technology’s contract manufacturing facility is regularly audited by a third-party registrar, as well as by customers, to ensure compliance with ISO 9001 and ISO 13485 requirements. The ability to adhere to ISO, regulatory, and customer requirements must be supported by a culture of compliance that is initiated by top management, and is one of the cornerstones to our success providing equipment in the cGMP environment.
Meeting Deadlines for Contract Manufacturing
The demands of the medical device industry require the selected contract manufacturing partner to have a relentless commitment to making scheduled dates. The CM should be able to demonstrate business systems and procedures in place for achieving, and maintaining aggressive schedules for the manufacture of your particular medical device.
Keller Technology has a variety of procedures that leverage technology to ensure the smooth flow of a program from concept to design. Throughout the manufacture, testing, and delivery of your medical device, you’ll find that our flexible system enables us to adapt to unforeseen customer driven changes.
Delivering on Medical Device Technical Specifications
Achieving technical specifications and milestones goes hand-in-hand with maintaining a schedule. The CM must have robust QA procedures, equipment, and tools in place to meet the rigorous technical quality specifications of the medical device industry, while also staying on schedule. Ultimately, to be successful the contract manufacturing company must foster a date-driven culture that emphasizes execution. At Keller Technology, key metrics are measured, documented, and analyzed. There is accountability to successfully execute to meet both schedule and technical requirements.