Medical Device Testing, Certification, Assurance & Auditing
Intertek supports the needs of a Medical Device manufacturer spanning their product life-cycle
Time to market starts with trusted partnership, and with the experience of more than 50 years Intertek has been partnering with manufacturers to provide global Medical Device testing, certification, inspection and assurance solutions.
Medical Industry Outlook and Global Trends
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Regulatory Requirements for Medical Equipment
Bring your Medical Device to market with a partner who can navigate regulatory requirements for IEC 60601-1, IEC 60601-1-2, MDR, IVDD, and the CB Scheme.
Electrical Medical Device Testing Solutions
Reach your target markets quickly and cost-effectively with electrical, electromagnetic compatibility (EMC), bluetooth and wireless testing, cybersecurity, software and mobile application testing and certification for your medical device.
Environmental & Regulatory Services
We fully support the medical device industry to comply with changing global health and environmental regulatory requirements and restrictions, such as RoHS, REACH and WEEE.
Medical Management Systems Certification & Auditing
From ISO 13485 to MDSAP, get to market with integrated compliance solutions and a committed, global auditing support network on your side.
Medical Device Materials Testing and Scientific Support Services
Medical device materials testing, chemical analysis and scientific support including safety assessment through extractables and leachables (ISO 10993-18), materials characterisation, failure investigations, and manufacturing QC testing supporting all stages of development and manufacturing.
Clinical Research Services
Multi-disciplined clinical teams who provide robust, GCP and ISO 14155 compliant clinical trials for low risk medical devices.
For medical products entering the Canadian market, SPE-3000 serves as the model code for the field evaluation of medical electrical equipment (MEE) and medical electrical systems (MES), specifically pertaining to safety from electric shock, fire and mechanical hazards.
FDA ASCA Pilot Program
The FDA's ASCA Pilot Program is aimed at ensuring quality and accuracy in medical device pre-market submissions. Ultimately the goal is to help make the process more efficient and to add confidence in the levels of safety, performance, and quality assurance.
*The Intertek legal entities that provide medical device management system certification services (including ISO 13485 and MDSAP) and Notified Body services (MDR 2017/745 and MDD 93/42/EEC) do not provide any consulting services. Clients who have used other Intertek legal entities’ consulting services are not eligible to receive management system certification services or Notified Body services from Intertek.