Comprehensive CDMO Services for Medical Devices
As an ISO 13485 certified Contract Development and Manufacturing Organization (CDMO), Ranfac offers vertically integrated solutions for product design, development, regulatory approval, and single-source manufacturing. Partnering with Ranfac means working with a dedicated project manager who will oversee every phase of your project, ensuring seamless integration and control over quality, costs, and lead times.
4-phase Product DEVELOPMENT & MANUFACTURING
Ranfac’s CDMO process encompasses multiple phases designed to drive successful product launches. We streamline all stages of the product life cycle, from Design Control to Corrective and Preventive Actions (CAPA), using a cloud-based digital document control system. Our rigorous quality management ensures compliance and efficiency throughout development, maintaining a dynamic, digitized Design History File (DHF) that is automatically updated through user inputs.
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 CDMO Process: From Start to Scale
All new projects begin with a sit-down with Ranfac’s senior leadership. Here, we can get to know each other and determine if there is mutual interest in partnering. By having a clear understanding of your needs, we will determine the best solutions to get your product to market as efficiently as possible. Every device has its own unique challenges. That’s why Ranfac does not operate under a one-size-fits-all model.
Once we understand the scope of your project, we will build out a project plan broken down into our 4-phase development process, detailing expected development timelines, estimated costs for tooling, engineering and regulatory submissions.
With the plan approved, your dedicated project manager will be assigned as your partner from design through launch to manage your design history file (DHF) and will work closely with Ranfac’s production and quality teams to ensure your device is designed for ultimate efficiency and consistent efficacy.
Ranfac will compile documentation packages and other relevant paperwork to make your regulatory filing go smoothly. Ranfac can work on your behalf with the FDA and other international regulatory bodies to submit for applicable regulatory clearances. Note that Class I devices do not require FDA submission although they do require the same level of documentation and testing as a Class II device.
Once the Alpha phase has been reached and the product has been released to manufacturing, Ranfac will launch at your pace. We understand it takes time to get a new product off the ground, which is why we offer low minimum order quantities.
We look forward to growing together, which is why we are constantly reinvesting in our infrastructure and technologies to stay ahead of future demand.
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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.
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