Regardless of what product development stage you are in, Intertek can help you speed-up your time to market. As medical device manufacturing companies work to embrace the sometimes complex factory production control and extended documentation requirements that the IEC 60601-1 (3rd edition) standard brings, on top of traditional testing.
Intertek provides contract testing, certification, auditing and chemical analysis services for medical devices. By combining unsurpassed analytical and technical expertise with excellent knowledge of regulatory issues across the world, we are able to help companies achieve approval and compliance for their medical devices.
Intertek has been providing quality and safety testing, inspection and certification services to companies across the globe for over 127 years. With over 35,000 employees at 1,000 sites internationally, we can provide support to companies for any market.
Testing and certification for medical devices
Intertek’s medical device testing and certification services can significantly improve time to market, and the company can partner with you to ensure all aspects of testing, certification and auditing are achieved in the most efficient way possible.
Intertek is an OHSA-approved nationally recognised testing laboratory (NRTL) and UKAS accredited in the UK. If you are looking to bring your device to multiple markets, we can provide all the region-specific expertise and certification to achieve compliance around the world. Depending on your requirements, this can include:
- IEC 60601-1 3rd edition standard and a range of particular standards for specific types of medial device: requirements for new and existing medical devices in North America and Europe
- IEC 60601-1-2:2007 electromagnetic compatibility (EMC): full-compliance testing in fully equipped EMC chambers for products at any stage in the development cycle
- Medical Devices Directive 93/42/EEC: compliance with requirements for appropriate medical device class to aid application for CE Mark and achieve EU approval
- In-Vitro Diagnostic Directive 98/79/EC: ensure compliance for in-vitro diagnostic devices to achieve CR Mark approval
Medical device certification for multiple markets
If you are looking to obtain certifications for your medical device in multiple countries, the IECEE CB scheme is ideal. It is designed to make medical device approval in multiple markets far simpler by enabling numerous national safety certifications to be obtained with just one test report. Medical devices tested through this scheme can gain approval in over 50 countries, including Japan, China, Canada and Australia.
Intertek is a CB testing laboratory and national certification body for the scheme, and issues more certificates for it than any other company in the world.
Auditing and certification for medical management systems
In many countries, a third-party audited management system is essential for companies looking to sell medical products of any type. Intertek can offer a complete service for this, which can cover the requirements of many different markets in one audit. As part of this we can include:
- ISO 13485:2003 quality management systems certification
- CMDCAS for market approval in Canada
- Health Canada / TGA MOU for Australian market approval
- Technical cooperation program (TGP) for quicker regulatory approval in Taiwan
- ISO 14971:2007 risk management
- Assessment of medical device directive (MDD) conformity for CE Mark approval
- Inspection for FDA accredited persons (AP)
- Pharmaceutical affairs law (PAL), Japan, compliance of quality system
- Dental appliance manufacturers audit scheme (DAMAS) QMS compliance assessment
Chemical analysis of medical materials
Complete chemical analysis of medical device materials is essential, and can be fully handled by Intertek. We can provide a wealth of different services depending on the nature of the device, including bioanalysis, QC testing, impurity and degradant identification, extractable and leachable testing, interaction assessments and stability testing.
The company can provide any materials analysis tests that are required for your medical device, and our expert staff will ensure that all assessments are performed to the highest standards.
Medical device performance testing
We also provide performance testing for medical devices, which, although not required for regulatory approval, can be a valuable asset in ensuring your device has the edge over your competitors.
This testing service is available for any type of product, as is an excellent way to demonstrate superiority over competition, validate claims and establish product failure rates.
Intertek Academy training courses for medical device manufacturers
Intertek training programs address a broad range of subjects and can be delivered either at one of our training centres attached to our laboratories, or on-site at your premises.
Operating at the forefront of international and local regulatory developments, customer and legal compliance requirements, as well as good manufacturing and compliance practices, our experts have the experience to assure your key staff, management and suppliers will be up-to-date on key compliance issues, technical expertise, and more.
We share our expertise through an extensive array of training and implementation programs, helping our clients and their supply chains understand regulatory requirements, improve their business processes, and meet customer demands. To find out more please visit our training course pages using the links at the bottom of the profile.
Medical device scientific support services
Intertek provides an extensive range of scientific support services to aid you in any aspect of your medical device development. We have laboratories across the UK and the world that are fully equipped with appropriate instrumentation and testing facilities, along with highly qualified, professional scientists and technicians, to undertake all work that is required.
Areas Intertek provides scientific support services include:
- Analytical support for research and development, including assay development for APIs, degradants, impurities and trace metals
- Failure analysis and material characterisation for implantable devices
- Combination device interaction assessment, including development of assays
- Medical device testing and stability to assess slow elution, batch release, dissolution at low solubility and controlled drug release patterns (DRP)
- Microbiology, auditing and regulatory services, including instrument validation and / or calibration, cGMP QA auditing and clean room validation
- Rapid response and manufacturing crisis, to provide problem-solving assistance in the event of a crisis or issue
To find out more about Intertek’s services, please contact us using the details or form below.
The role of electromagnetic compatibility in implantable medical device design and testing has become increasingly important as we rely more and more on electronics in our lives.
The 3rd Edition of IEC 60601-1 represents a shift in philosophy from the 2nd Edition, including a greater emphasis on risk management and essential performance. As with any other standard change, a failure to implement these new requirements in a timely manner could cause costly delays in getting your device to market.
Intertek, the leading quality solutions provider to industries worldwide, announces a series of complimentary webinars that will began on 8 August and will continue through November.
Regardless of what product development stage you are in, Intertek can help you speed-up your time to market.