Medical Devices Sector
Medical Devices Testing, Certification and Conformity
Overview
Medical Devices sector: an overview of conformity processes
In the EU, medical devices fall under the MDR (Regulation (EU) 2017/745), and in vitro diagnostic devices under the IVDR (Regulation (EU) 2017/746). The quality system is established via ISO 13485; biocompatibility is assessed via ISO 10993, electrical safety via IEC 60601-1, software via IEC 62304, and usability via IEC 62366-1.
How we work
Six steps from scope to certificate
Scope
We determine your product, target market and sector; the required legislation list is produced.
Quote
Testing and audit items are priced separately; the quote is delivered within 24 hours.
Sample / Planning
Sample requirements are shared, or an on-site audit is scheduled.
Testing & Audit
Testing or audit is carried out according to the method of the relevant standard.
Report & Document
A report is issued; if within certification scope, the process proceeds to the decision stage.
Maintaining the validation
Surveillance audits and legislative changes are tracked.
Product groups
Medical Devices sector: what do we test?
- 01Active medical devices and monitors
- 02Implants and surgical instruments
- 03Single-use sterile devices
- 04In vitro diagnostic kits and analysers
- 05Medical device software (SaMD)
Services
The work we carry out in this sector
From testing laboratories to inspection, surveillance, audit, verification and calibration — all the services the Medical Devices supply chain needs are under one roof.
All services
Standards
Standards referenced by the sector
Content is linked to standards based on the product's intended use, target market and technical characteristics.
- ISO 11607end product sterile barrier packaging
- ISO 11737-1determination of microbial load in medical devices
- ASTM F1980accelerated aging in packaging
- ASTM F88peeling resistance in sealing seam
- IEC 60601-1Basic safety in medical electrical devices
- IEC 60601-1-2electromagnetic compatibility in medical electrical devices
- IEC 62304medical device software lifecycle processes
- IEC 62366-1usability engineering in medical devices
- ISO 10993-10skin sensitivity assessment
- ISO 10993-11systemic toxicity
- ISO 10993-23irritation assessment
- ISO 10993-3genotoxicity, carcinogenicity and reproductive toxicity
- ISO 10993-4evaluation of interaction with blood
- ISO 10993-5in vitro cytotoxicity
- IEC 60335Safety in home and similar electrical devices
- IEC 61010Safety in measuring, control and laboratory devices
- IEC 62368Security in audio, video and information technology devices
- IEC 60601-1Basic safety in medical electrical devices
- CSA C22.2Canadian electrical equipment safety standards
- EN 12102Noise measurement in heat pumps and air conditioners
- EN 14511Performance and capacity in heat pumps and air conditioners
- EN 14825Seasonal performance in air conditioners and heat pumps
- EN 62115safety in electric toys
- IEC 60034rotary electric machines
- IEC 60112Comparative tracking index in solid insulation materials
- IEC 60204-1electrical equipment safety in machines
- IEC 60227PVC insulated cables
- IEC 60228conductors of insulated cables
- CISPR 32emissions in multimedia devices
- MIL-STD-461electromagnetic interference in military systems
- CISPR 25Radio degradation of in-car components
- IEC 60601-1-2electromagnetic compatibility in medical electrical devices
- IEC 61000-3-2harmonic current emission
- IEC 61000-3-3voltage fluctuation and flicker
- IEC 61000-4-11voltage sag and short interruption immunity
- IEC 61000-4-2electrostatic discharge (ESD) immunity
- IEC 61000-4-3radiated RF field immunity
- IEC 61000-4-4rapid transient/burst (EFT) immunity
- IEC 61000-4-5sudden surge immunity
- IEC 61000-4-6conducted RF immunity
- ISO 10605electrostatic discharge in vehicles
- ISO 11452radiated field immunity in vehicles
- UN 38.3Transport safety tests on lithium batteries
- ISO 11607end product sterile barrier packaging
- ASTM D3985oxygen permeability (OTR)
- ASTM D4728random vibration in packaging
- ASTM D5276free fall test on packages
- ASTM D642compression testing of packages
- ASTM D999vibration testing on packaging
- ASTM F1249water vapor permeability (WVTR)
- ASTM F1980accelerated aging in packaging
- ASTM F88peeling resistance in sealing seam
- ISTApackaging transport performance test series
- ASTM D1434Gas permeability in plastic film and sheet
- ASTM D1709free falling dart impact resistance in plastic film
- ASTM D3330peel adhesion on pressure sensitive tape
- RTCA DO-160Environmental conditions and test methods in aviation equipment
- MIL-STD-810environmental engineering assessments and laboratory tests
- ASTM G154fluorescent UV accelerated aging
- ASTM G155Accelerated aging with xenon arc
- IEC 60068-2-1low temperature (cold) test
- IEC 60068-2-14temperature change test
- IEC 60068-2-2high temperature (dry heat) test
- IEC 60068-2-30cyclic moist heat testing
- IEC 60068-2-6sine vibration test
- IEC 60068-2-78constant moist heat test
- IEC 60068series of environmental testing methods
- IEC 60068-2-11series of environmental testing methods
- IEC 60068-2-18series of environmental testing methods
- IEC 60068-2-38series of environmental testing methods
Certification
Documents that enable your product to reach the market
Global Market Access
Medical Devices which market will you offer your product to?
Medical Devices when offering products to different markets, technical legislation, tests, documents and conformity requirements may vary by country and region.
View all markets
Explore other sectors
