Medical Device Management
Provider of regulatory, quality and manufacturing support for medical device companies. Services include implementation and maintenance of ISO 13485 quality management systems, regulatory compliance and technical file preparation for CE/UKCA/UDI, subcontract and cleanroom manufacturing, product testing, and EU/UK market representation. Works with clients from startups to multinationals across a range of device types.
Industries
Nr. of Employees
small (1-50)
Medical Device Management
31 Braintree Business Park, Blackwell Drive, Braintree, Essex, CM7 2PU, United Kingdom
Patents
Products
Depth-of-anaesthesia monitor using auditory evoked potentials
Development support for a compact depth-of-anaesthesia monitoring system based on auditory evoked potentials, including mechanical housing design, coordination of electronics and software development, technical file compilation, regulatory approval, manufacturing and testing.
Single-use magnetic blood filtration device (case example)
Support for development and manufacture of a single-use magnetic blood filter, including mechanical design of custom molded parts, labelling design, materials and supplier identification, facilitation of biocompatibility and sterility testing, implementation of cleanroom manufacturing and establishment of sterilization processes.
Depth-of-anaesthesia monitor using auditory evoked potentials
Development support for a compact depth-of-anaesthesia monitoring system based on auditory evoked potentials, including mechanical housing design, coordination of electronics and software development, technical file compilation, regulatory approval, manufacturing and testing.
Single-use magnetic blood filtration device (case example)
Support for development and manufacture of a single-use magnetic blood filter, including mechanical design of custom molded parts, labelling design, materials and supplier identification, facilitation of biocompatibility and sterility testing, implementation of cleanroom manufacturing and establishment of sterilization processes.
Services
Advice and support on implementing and maintaining ISO 13485:2016-compliant QMS, tailored to client needs, including audit support.
Preparation and updating of regulatory documentation to support CE marking, UKCA marking, MDR and UDI requirements.
Subcontract assembly and manufacture of medical devices including cleanroom processes for sterile products and coordination of sterilization.
Product testing including final release testing, real-time aging and accelerated aging studies.
Legal representation services to enable market placement in the EU and UK for companies without local presence.
Advice and support on implementing and maintaining ISO 13485:2016-compliant QMS, tailored to client needs, including audit support.
Preparation and updating of regulatory documentation to support CE marking, UKCA marking, MDR and UDI requirements.
Subcontract assembly and manufacture of medical devices including cleanroom processes for sterile products and coordination of sterilization.
Product testing including final release testing, real-time aging and accelerated aging studies.
Legal representation services to enable market placement in the EU and UK for companies without local presence.
Expertise Areas
- Quality management systems (ISO 13485)
- Regulatory compliance and technical file compilation (CE/UKCA/MDR/UDI)
- Subcontract and cleanroom manufacturing
- Device testing and ageing studies
Key Technologies
- Cleanroom assembly and sterile manufacturing
- Injection moulding for device housings
- PCB and embedded software development
- Biocompatibility and endotoxin testing
News & Updates
Safety and performance information and extract of instructions supplied for an electronic tourniquet device.
Device information / instructions for a spray nozzle product (120mm).
Device information / instructions for a spray nozzle product (230mm).
Device information / instructions for a heat patch product.
Successful recertification audit completed; latest ISO 13485:2016 certificate available for download.
Safety and performance information and extract of instructions supplied for an electronic tourniquet device.
Device information / instructions for a spray nozzle product (120mm).
Device information / instructions for a spray nozzle product (230mm).
Device information / instructions for a heat patch product.
Successful recertification audit completed; latest ISO 13485:2016 certificate available for download.