Original Equipment Manufacturing for Medical Devices

As an ISO 13485 certified medical device original equipment manufacturer, Ranfac offers vertically integrated solutions for product design and development, manufacturing process development, regulatory approval, and single-source manufacturing. When you partner with Ranfac, you will be assigned a dedicated project manager to oversee each phase of your production process. By offering these integrated solutions in-house, we’re uniquely positioned to control quality, costs, and lead times for OEM projects.

4-phase Product Design & Development

Ranfac’s OEM process consists of multiple phases that are designed to drive successful launches. We streamline all stages of the product life cycle from Design Control to CAPA with a cloud-based digital document control system. Our robust quality control ensures compliance and efficiency throughout the development process as it creates a ‘living’ digitized Design History File (DHF), which is automatically revisioned through user inputs in the system.

Phase 1 | Project Planning

This phase includes defining the project to ensure all product requirements are understood. During this stage, customers coordinate extensively with Ranfac’s customer application engineer and design engineer to ensure all design inputs are understood, including: Marketing requirements, user needs, and patient needs. We then derive product design specifications from user needs by translating these needs into measurable engineering requirements. All requirements are reviewed to ensure they can be verified and validated. We initiate a risk management plan and preliminary risk assessment to ensure all risks are being managed and mitigated accordingly throughout the 4 phases of the development process.

Phase 2 | Design Output

Phase 2 is dedicated to risk assessments as per the risk management plan. During this phase, we complete detailed design and design output documentation, including engineering drawings, routers, and BOMs. Manufacturing activities are documented during this phase. The design out output documentation includes:

Traceability of design input to design output
Adequate information to purchase any required components
Reference to product acceptance criteria
Specific characteristics that are essential for proper functioning of the device
Written and approved validation and verification protocols

Phase 3 | Design Verification

During this phase, we complete design verification and validation to confirm that design inputs are met. Prior to completing verification testing, protocols are written and approved that contain the following:

Methods for testing
Statistical rationale
Acceptance Criteria

All protocols are executed, and reports are written detailing the testing results. Each report includes:

Methods
Part number and revision of the device tested in verification
Summary of the protocol including, methods, acceptance criteria, and selection of sample size
Deviations
Results including raw data
Conclusions from the testing

Once verification and validation are complete, the risk management documents, V&V results, labeling and regulatory submission status are all finalized and reviewed.

Phase 4 | Design Transfer

During this phase, the product is transferred to manufacturing by way of releasing all documents to Alpha Revision level. The Medical Device File is created and released identifying all of the documents necessary to manufacture the product. Ranfac processes a design Transfer checklist during the final design review to ensure operations, quality, and engineering are all in agreement that the product can be released to production before the first operations-controlled build. This 4-phased approach to launching products has proven very successful for both Ranfac and our customers.

Our Proven Medical Device Manufacturing Process

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Case Study

Learn how Ranfac helped a leading virtual medical device development company overcome product design challenges to custom-manufacture and launch a transformative device that rapidly penetrated global markets.

Testimonials

What People Say

“Without Ranfac, I would have failed. Failed to change a process that was affecting women negatively all around the world. Ranfacʼs COO, Barry Zimble, knew the importance of this. He knew the initial process as they were already working in this space, he could use the names of the original inventors but he understood the importance of changing the manufacturing. It was their deep experience in this field that was a really important reason to go for Ranfac. Bringing a new device is a journey and it is not a straight line, you canʼt plan everything and have it all to fall in line. It is a very bumpy process, and Ranfac really was there for us with every one of these bumps. They really stuck with us and were very creative with the solution to get us back on track. We kept throwing curveballs at them and they were incredibly resilient.”

“Ranfac has supplied my company for over twenty years. We have developed a number of new products together and overcame many manufacturing and supplier issues over the years. It was always teamwork to resolve whatever challenge we incurred - no finger pointing or negotiation. It is so refreshing to share open discussions with the Ranfac team to provide quality solutions to our customers. Of course, Ranfac COO, Barry Zimble, was always actively involved as the quarterback for the Ranfac team. He's always been realistic, pragmatic and candid as we worked through our challenges. His integrity is beyond reproach. If he commits his team to a goal, you can count on them.Over the years, Ranfac has continually re-invested in their equipment, facilities and their people. When I chose Ranfac as our primary supplier, it was one of the best business decisions that I ever made.”

Ranfac was the first group—and really only group—that we approached, because I knew that they had an unparalleled reputation for putting out a very high-quality product and also they have a completely integrated facility there. They are recognized as being the best at their particular specialty and they were the sole source. What makes their products unique is quality, innovation, and response time.

“When BONESUPPORT was looking for a precise, cost-effective solution to deliver Cerament in multiple applications, Ranfac made it simple. We now have a proven technology that works easily and efficiently with our product portfolio. Thanks to Ranfac’s attention to detail and creative approach, they’ve helped us to meet the needs of our customers. Looking forward to our next project.”

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Learn how Ranfac’s single-source original equipment manufacturing of medical devices can help you lower costs and maximize quality.

Original Equipment Manufacturing for Medical Devices

4-phase Product Design & Development

Phase 1 | Project Planning

Phase 2 | Design Output

Phase 3 | Design Verification

Phase 4 | Design Transfer

Our Proven Medical Device Manufacturing Process

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