OUR PROCESS

At Contract Medical Manufacturing, we believe in co-development. We build long-term relationships with our clients that go beyond meeting specifications. CMM works closely with our customers to optimize manufacturability, streamline supply chain management, and reduce costs through product design enhancements. We build a true partnership based on trust, where both parties are sharing their expertise to achieve the final goal. Depending on your needs, CMM can assist in every step of the medical device development process. From design input to final process verification and validation activities, CMM has the knowledge and expertise to help drive your projects forward.

CMM will leverage its knowledge in the device design and development process. By utilizing our tested six-phase D&D process, CMM works closely with our customers to produce a comprehensive Design History File (DHF) that will include the following:

• Detailed Project Plans, Design and Development Planning
• Design Inputs
• Design Outputs, Verification and Validations
• Design Transfer
• Product release for distribution
• Post Market Surveillance

The CMM process development phase starts with trial assembly early on in the development cycle, and progresses as the product evolves. Process Failure Mode Effects Analysis (pFMEA) is started early and reviewed throughout the process. This provides the guidance for the development of a Master Validation Plan, which determines what qualifications/validations will be required. The protocols are executed and reports written and filed with the Device Master Record (DMR).

QUALITY SYSTEMS

To ensure the highest quality, CMM teams up with the supplier to ensure a smooth transition of inspection criteria on components. CMM focuses on critical attributes that are jointly developed between the customer and the supplier to determine component risk levels and mitigations. CMM maintains an Approved Supplier List (ASL) and trends supplier quality performance and on-time delivery. A comprehensive DMR will be developed for every customer product and maintained as part of the quality and change control system.

ELECTRICAL MECHANICAL

CMM strives to use the best manufacturing methods available to keep costs down. We specialize in electrical/mechanical assembly in which we focus on the contract assembly of complex mechanical and electro-mechanical assemblies. We have all of the necessary skills and experience to meet your assembly needs. We will provide you with fully tested medical devices built to your exact specifications, and delivered according to your production requirements.

Environmentally Controlled Area

CMM offers Clean Room capabilities (Class 100,000 – ISO Class 8) for assembly and packaging (both blister and pouch). This newly expanded production area will meet our customers’ most critical manufacturing requirements for testing, assembly and packaging. The environment of the Class 100,000 Clean Room is maintained through a HEPA filtration system, as well as humidity and temperature controls. Our priority at Contract Medical Manufacturing is to provide our customers with a quality assembly that complies with their specifications. By expanding this Class 100,000 ECA to our facility we are demonstrating our deep commitment to assisting our customers in meeting their needs and providing a more complete manufacturing solution.

STERILE BARRIER PACKAGING

CMM is prepared to handle all of your needs, including sterile barrier packaging. CMM has both blister pack and pouch capabilities. It is critical that packaging designs maintain integrity from the point of manufacture to the surgical field. CMM utilizes processes that guarantee the integrity of product packaging.