MEDICAL DEVICE
DESIGN & DEVELOPMENT
This process for releasing products consists of multiple phases that are designed to ensure a successful launch. Ranfac streamlines all stages of the product life cycle from Design Control to CAPA. Our cloud-based digital document control system helps to ensure 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 & DESIGN INPUTS
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This phase includes defining the project to ensure all product requirements are understood. Extensive customer interaction between the customer application engineer and the design engineer at Ranfac occurs during this phase to ensure all design inputs are understood including: Marketing requirements, user needs and patient needs. Product design specifications are then derived from the user needs translating needs into measurable engineering requirements. All requirements are reviewed to ensure they are able to be verified and validated. A risk management plan and preliminary risk assessment are initiated during this phase to ensure all risks are being managed and mitigated accordingly throughout the 4 phases of the development process.
PHASE 2 DESIGN OUTPUT
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Phase 2 is dedicated to risk assessments as per the risk management plan. During this phase, detailed design and design output documentation will be completed including engineering drawings, routers and BOMs. Manufacturing activities are documented during this phase. The design out output documentation will include:
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Traceability of design input to design output
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Provide adequate information to purchase any required components
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Include reference to product acceptance criteria
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Specify characteristics that are essential for proper functioning of the device.
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Validation and verification protocols written and approved.
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PHASE 3 DESIGN VERIFICATION
During this phase, design verification and validation will be completed to confirm that design inputs are met. Prior to completing verification testing, protocols are written and approved that contain the following:
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Methods for the testing
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Statistical rationale
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Acceptance Criteria
All protocols are executed, and reports are written detailing the results of the testing. Each report includes:
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Methods
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Part number and revision of the device tested in verification
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Summary of the protocol including, methods, acceptance criteria, and selection of sample size
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Deviations
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Results including raw data
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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.
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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 to be very successful for Ranfac Corp and our partners.
OUR PROCESS
READY TO START?
Get in touch with one of our medical manufacturing experts to start the manufacturing process today.
CASE STUDY
HEALTH BEACONS
Health Beacons, a virtual medical device development company, came up with the idea for a device in 2015, to deploy a miniature radio frequency identification (RFID) Tag for a wire-free breast lesion guidance system. The purpose of this invention was to change the traditional process of using a localization wire for breast lesion marking.
CLIENT TESTIMONIALS
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.
