Medical Devices
FMP is expert at providing safe solutions for all of your medical device contract packaging requirements including medical devices and equipment, healthcare and cosmetic products.
How to decide whether you need specialist medical device assembly
Specialist medical device assembly and packing is relevant when a product needs to be assembled, labelled, filled or packed within a controlled environment, under a quality system that supports its intended use and regulatory requirements.
FMP works with medical device, healthcare and cosmetic product requirements using multiple cleanrooms from ISO Class 7 to ISO Class 8. The available machinery and supporting laboratory equipment allow our team to develop a bespoke route around the device, component set, pack format, testing requirement and expected production demand.
By partnering with FMP, you bring cleanroom operations, ISO 13485 quality controls, packing expertise, analytical support and regulatory awareness together within one accountable manufacturing route.
ISO Class 7 or ISO Class 8: which cleanroom route is appropriate?
The appropriate environment depends on the intended use of your device, its classification, contamination risk, assembly process, packaging system and sterilisation strategy. FMP can review the requirement with you and define a suitable route using our ISO Class 7 and ISO Class 8 facilities, including the controls and documentation needed to support sterile or non-sterile products.
FMP capabilities
• Medical device, healthcare and cosmetic assembly and packing
• Multiple ISO Class 7 and ISO Class 8 cleanrooms
• ISO 13485-controlled quality systems
• Assembly, labelling, filling and packing equipment
• Analytical laboratory testing support
• Regulatory and quality support
Formats and production options
• Sterile and non-sterile product routes
• Customer-supplied components and established device specifications
• Bespoke assembly and packaging configurations
• Low-volume and specialist production through to growing demand
• Product transfer and new product introduction support
• Project review for device classification, packaging and sterilisation requirements
How medical device assembly and contract packing works
Medical device assembly and packing requires a controlled process that connects component handling, cleanroom selection, documented work instructions, inspection, testing, packaging and release requirements.
FMP provides:
✓ Review of the device, intended use, classification, components, assembly steps, packaging specification, sterilisation strategy and expected production volumes.
✓ Selection of the appropriate ISO Class 7 or ISO Class 8 cleanroom and suitable assembly, labelling, filling or packing equipment.
✓ Documented production and quality controls under FMP's ISO 13485 quality management system, supported by analytical testing where required.
✓ A customer-specific route for transfer, validation, routine manufacture and packing, with regulatory and technical documentation considered throughout the project.
Rather than forcing a device into a standard packing process, FMP combines controlled cleanroom facilities, flexible equipment, testing support and medical manufacturing experience to build a practical route that's right for you.
Medical device assembly and packing
Cleanroom assembly and packing for medical devices and components where controlled handling, repeatable processes, inspection and traceability support reliable supply.
Healthcare and cosmetic products
Bespoke assembly, labelling, filling and packing routes for healthcare and cosmetic products that require a controlled environment and documented quality controls.
Product transfer and new requirements
Support for established specifications, product transfers and new customer requirements where cleanroom selection, equipment, testing, packaging and compliance need to be considered together.
The benefits of outsourcing medical device assembly and packing
Outsourcing medical device assembly and packing to FMP enables you to:
✓ Access ISO Class 7 and ISO Class 8 cleanrooms and ISO 13485-controlled quality systems without investing in dedicated facilities.
✓ Bring assembly, labelling, filling, packing and supporting analytical testing into one controlled route.
✓ Use flexible equipment and experienced production support for bespoke, low-volume, transferred and growing product requirements.
✓ Connect manufacturing decisions with device classification, packaging, sterilisation and regulatory documentation requirements.
✓ Reduce supply and transfer risk by working with a partner experienced in quality-sensitive medical, healthcare and cosmetic operations.
FMP provides the manufacturing, packaging and compliance infrastructure needed to move regulated and quality-sensitive products towards reliable market supply.
Enquiry
Consultation
Quote
Delivery
What to look for in a medical device assembly partner
A medical device assembly partner needs to offer more than cleanroom space. Look for a supplier that can connect the correct controlled environment with documented quality systems, suitable equipment, inspection and testing, regulatory understanding and dependable delivery.
FMP supports you with:
✓ ISO 13485-certified quality systems and cleanroom facilities appropriate to the product requirement.
✓ Experience in medical device, healthcare and cosmetic assembly and packing.
✓ A practical range of assembly, labelling, filling and packing equipment.
✓ Analytical testing and quality support that complement production activities.
✓ Understanding of sterile and non-sterile routes, packaging and sterilisation considerations.
✓ Flexible support for bespoke manufacture, technical transfer, new product introduction and changing demand.
This gives you one accountable partner across cleanroom assembly, packing, quality, testing and practical route development.
FAQ'S
We provide cleanroom assembly, labelling, filling and packing for medical device, healthcare and cosmetic requirements. Each project is reviewed around the product, components, intended use, classification, process, packaging, testing and expected production demand before the route is confirmed.
FMP has multiple cleanroom facilities ranging from ISO Class 7 to ISO Class 8. The appropriate environment depends on the device, contamination risk, assembly process, intended use, packaging system and sterilisation strategy.
Yes. FMP supports manufacturing and packaging solutions for sterile and non-sterile medical device requirements. The agreed process must reflect the intended use, device classification, cleanroom route, packaging and sterilisation requirements.
Yes. FMP's assembly and packing operations are supported by laboratory testing equipment and an ISO 13485-accredited quality management system. The exact inspection, analytical testing and documentation requirements are defined for each project.
Yes. Our team can review established specifications, customer-supplied components, product transfers and bespoke requirements. The team assesses the assembly steps, equipment, cleanroom, packaging, quality controls, documentation and production demand before defining a suitable route.
Start with an enquiry outlining the device, intended use, classification, component set, current specification, assembly and packing requirements, sterilisation strategy, testing needs, expected volumes and target market. FMP will review the requirement, discuss the technical and quality considerations, and provide a quotation before production.
