Intertek supports the needs of a Medical Device manufacturer spanning their product life-cycle
Medical devices encompass a broad range of instruments, apparatuses, machines, implants, or other similar articles intended for use in the diagnosis, treatment, monitoring, and/or prevention of illnesses and diseases. They can vary widely in complexity and purpose. Some common medical device categories include:
- Diagnostic Equipment
- Surgical Instruments
- Therapeutic Equipment
- Monitoring Devices
- Implantable Medical Devices
- Dental Devices
- Assistive Devices
- In vitro Diagnostic Devices
- Health Monitoring Devices
- Home Healthcare Devices
- Fitness Devices
- Laboratory Equipment
Intertek's Solutions for Medical Devices
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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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.
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.
The FDA's ASCA 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.
Our global network of scientists, engineers, and regulatory specialists provide support to navigate complex scientific, regulatory, environmental, health, safety, and quality challenges throughout the value chain.
The medical device industry faces specific challenges when bringing their products to the global market with strict and complex global regulations. Our Auditing and Certification Services offer a unique combination of in-depth knowledge and global presence.
Medical device materials testing, chemical analysis and scientific support
Multi-disciplined clinical teams who provide robust, GCP and ISO 14155 compliant clinical trials
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.
- ETL Mark The Industry's Fastest Certification Program
- Search and Buy Medical Device Standards
- Reese's Law – ANSI/UL 4200A-2023
- My Test Central
- Certification Marks
- Global Research & Certification
- Medical Podcast - Compliance with Clarissa
- Satellite Data Acceptance Program
- Planning for Quality through Disruptions
- Intertek's world-class team of Medical Experts
- Intertek Protek - The world’s first industry-agnostic, end-to-end health, safety and wellbeing assurance program
As a leading provider of respiratory protection device testing, Intertek can assist you with comprehensive testing requirements and pre-certifications, expediting your products to market and into the hands of patients and providers.
** 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.