Medical Engineering Technologies
Medical Engineering Technologies (MET) has been supporting medical device manufacturers and developers since 1997, providing comprehensive testing services including device validation, biocompatibility, chemical characterization, packaging validation, and more. With over 25 years of experience, MET operates globally, offering reliable, accurate, and standards-compliant testing to ensure the safety, performance, and regulatory compliance of medical devices and combination products.
Industries
Nr. of Employees
small (1-50)
Medical Engineering Technologies
Products
Guidebook: Device validation and verification booklet
Downloadable guidebook covering device validation and verification topics for medical device developers.
Technical papers on extractables & leachables and pre-filled syringe validation
Published technical papers and white papers addressing E&L testing and design validation testing for pre-filled syringes and drug-delivery systems.
Guidebook: Device validation and verification booklet
Downloadable guidebook covering device validation and verification topics for medical device developers.
Technical papers on extractables & leachables and pre-filled syringe validation
Published technical papers and white papers addressing E&L testing and design validation testing for pre-filled syringes and drug-delivery systems.
Services
Lab-based validation and verification of medical device packaging and sterile barrier systems, including seal integrity, accelerated ageing, and transit simulation to support regulatory requirements.
Non-clinical testing programme for combination products covering chemical interactions, dose accuracy, stability, functional performance, particle analysis and RLD predicate comparisons.
Comprehensive ISO-standards-based testing for pre-filled syringes and needle-based devices including ISO 11040/11608 performance, air-transport validation, extractables & leachables, and usability studies.
Biological safety testing and planning in line with ISO 10993 and ISO 18562 for devices including respiratory components, addressing particulate, VOCs and condensate leachables.
Analytical programmes to detect, identify and quantify extractable and leachable species from device materials and packaging to inform toxicological risk assessments.
Preparation of test protocols, risk analyses and project plans for verification/validation testing and regulatory submissions, with rapid protocol turnaround following contract initiation.
Lab-based validation and verification of medical device packaging and sterile barrier systems, including seal integrity, accelerated ageing, and transit simulation to support regulatory requirements.
Non-clinical testing programme for combination products covering chemical interactions, dose accuracy, stability, functional performance, particle analysis and RLD predicate comparisons.
Comprehensive ISO-standards-based testing for pre-filled syringes and needle-based devices including ISO 11040/11608 performance, air-transport validation, extractables & leachables, and usability studies.
Biological safety testing and planning in line with ISO 10993 and ISO 18562 for devices including respiratory components, addressing particulate, VOCs and condensate leachables.
Analytical programmes to detect, identify and quantify extractable and leachable species from device materials and packaging to inform toxicological risk assessments.
Preparation of test protocols, risk analyses and project plans for verification/validation testing and regulatory submissions, with rapid protocol turnaround following contract initiation.
Expertise Areas
- Medical device design validation and verification
- Packaging validation and sterile barrier system testing
- Pre-filled syringe and auto-injector testing
- Combination product testing (drug/device/biologic)
Key Technologies
- Accelerated and real-time ageing chambers
- Transit simulation rigs (vibration, drop, reduced-pressure chambers)
- Seal integrity and burst/bubble emission testing methods
- Tensile/peel and burst strength testing
News & Updates
ISO 11607-2 Packaging Validation Standards Update
The revision and upcoming publication of ISO 11607-2 and Part 1 standards emphasizing contamination prevention and human factors.
Transit Testing for Medical Devices Webinar
Webinar on transit validation testing for pre-filled syringes and auto-injectors, including air transport effects.
ISO 18562 Series for Respiratory Components
Guidance and updates on ISO 18562 standards for biocompatibility of respiratory gas pathways.
Biocompatibility and Chemical Characterisation
Latest news on biocompatibility assessment, chemical analysis, and extractables/leachables testing.
Medical Device Packaging Validation News
Updates on ISO 11607 standards, packaging validation, and transit testing.
Webinar and guidance on the key aspects of pre-filled syringe design and validation.
ISO 11607-2 Packaging Validation Standards Update
The revision and upcoming publication of ISO 11607-2 and Part 1 standards emphasizing contamination prevention and human factors.
Transit Testing for Medical Devices Webinar
Webinar on transit validation testing for pre-filled syringes and auto-injectors, including air transport effects.
ISO 18562 Series for Respiratory Components
Guidance and updates on ISO 18562 standards for biocompatibility of respiratory gas pathways.
Biocompatibility and Chemical Characterisation
Latest news on biocompatibility assessment, chemical analysis, and extractables/leachables testing.
Medical Device Packaging Validation News
Updates on ISO 11607 standards, packaging validation, and transit testing.
Webinar and guidance on the key aspects of pre-filled syringe design and validation.