Medical Devices Total Quality Assurance Solution

Scientific Support Services

Intertek is a leading provider of scientific support services, having both the specialist instrumentation and expert capability for the chemical and physical analysis of medical devices at all stages of the design, trial and manufacturing process. Our scientific capability uniquely covers the fields of metals, polymers and pharmaceuticals with over 1000 expert scientists and 28 research laboratories worldwide. Intertek provides long term scientific research and rapid response problem solving with GLP certification, cGMP compliance and ISO 17025 accreditation. More scientific support services include: 

• R&D analytical support
• Material characterization and failure analysis for medical devices
• Interaction assessments in combination devices
• Stability and medical device testing

Audit, Certification and Review Services

Intertek is a true “one-stop-shop” of auditing, certification and review services for the medical industry. Our unique combination of expertise has brought confidence and assurance to thousands of organizations all over the world. The audit, certification and review services offered by Intertek include: 

• Management system certification
• Second-party-auditing

We partner with you to share our knowledge, keeping you on the cutting edge of latest regulatory requirements. 

At Intertek, time to market starts with partnership. With over 110 years of experience, we combine our expertise with our passion for solutions that guide your products through today’ s constantly changing regulatory process and into the hands of customers faster than ever before.

At Intertek, we have the experience you need for the devices you’re developing. We understand that providing early access to our experts saves you time and money. Our expertise helps you overcome regulatory difficulties and shorten your time to market, and our knowledge of the standards accelerates turnaround time in your certification process.

Knowledge-Based Services

• Education and training
• Design for market entry services
• Technical file support for the medical device directive (MDD)
• Process design for risk management

GMAP (Global Market Access Program) 

• Medical device single audit program (MDSAP)

The Medical Device Single Audit Program was developed by a group of medical device regulators to allow recognized third-party auditors to conduct a single audit of a medical device manufacturer that will cover ISO 13485 and their respective regulatory requirements. The regulatory authorities that are currently participating in the MDSAP Pilot Program are Australia – TGA, Brazil – ANVISA, Canada - Health Canada, U.S. – FDA, Ministry of Health, Labour and Welfare (MHLW) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).

As an approved third-party testing services provider in countries, Intertek helps customers access the following markets.

• North America
• Brazil
• Australia
• Nigeria
• Russia

Our product conformity for exports and pre-shipment inspection programs

Intertek helps you comply with the requirements of the following countries: Kuwait, Nigeria, Algeria, Bangladesh and Uzbekistan. Additionally, we can help you trading with those countries around the world that have strict safety, performance, or pre-shipment inspection requirements for imports.

Safety and Performance Testing 

Intertek provides safety and performance testing services based on the below standards, along with marks and schemes that recognize the safety and performance of products and ensure the products comply with the compulsory requirements for accessing your target markets.

• IEC 60601-1
• ETL listed mark for North America
• CE marking for the European Union
• S mark
• CB scheme
• Tick Mark 
• Performance testing
• Accelerated stress tests
• RoHS directive for hazardous substances