Medical Development Services

This new consultancy service is being offered to Design and Development departments, Design Agencies and Healthcare Professionals.

As a highly experienced manufacturer we work with you to develop your product or concept from the design phase through to the manufacturing transfer phase and launch. Two vital archives, the Design History Record and Device Master Record, are generated throughout this process. These are then available for handover as the blueprint for higher volume manufacture, allowing you complete freedom of choice in selection of production supplier and location.

This new approach to product development achieves:-

More Freedom

• To source globally from the best vendor using the blueprints of the DMR and DHR; there is no need to commit to the ultimate volume manufacturer in advance.
• To design new devices without having to bring a manufacturer on board until all the development issues have been resolved.

Greater Flexibility

• In how you pay for development work; costing is phased and payment is only required when milestones are achieved, meaning projects can be stopped at completion of any phase.
• You have no obligations to a manufacturer if your device does not achieve its volume production potential.

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To provide these benefits, our activities and deliverables are as follows:

1. Design and Process Development:

• Design for manufacture and application of design tools, eg. mouldflow, tolerance analysis.
• Advise on material selection.
• Production of tooling, mouldings and assemblies to provide prototypes for trials.
• Creation of a preliminary manufacturing plan.

2. Design Verification and Validation:

• Build Design Verification and Validation units.
• Perform Verification and Validation Testing:
  • Reliability
  • Performance
  • Sterilisation
  • Biocompatibility
  • Packaging Evaluation
  • Accelerated ageing
• Prepare and submit regulatory submissions

3. Manufacturing Setup and Optimisation:

• Develop a detailed manufacturing plan.
• Design process flow layout.
• Design and procure/make tooling, fixtures and equipment.
• Establish trials, perform capability studies, measure and optimise the processes.
• Complete process equipment and infrastructure validations; service and maintenance protocols, cleaning protocols etc.
• Complete Device Master Record (DMR)
• Close Design History File (DHF)

4. Manufacturing Process Validation and Transfer:

• Set up training and protocols for staff.
• Build initial product launch volumes.
• Transfer product to manufacturing systems.
• Presentation of Device Master Record (DMR) and Design History Record (DHR) to customer.

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