Why you should choose our BSI and CSA Group Alliance to help you access global markets
Achieving global market access for medical devices quickly becomes a costly and time-consuming mission. The alliance between CSA Group as one of the world's leading medical device testing organizations and BSI, one of the leading Notified Bodies in Europe, brings together an unrivalled mix of expertise, enabling you to create and bring your medical devices to patients and healthcare professionals all over the world - FASTER and more PREDICTABLY.
BSI Medical Devices offers certification services to support your global market access goals and are:
- A designated European Notified Body
- An accredited ISO 13485 Certification Body
- A recognized Auditing Organization under the Medical Device Single Audit Program, MDSAP
- A recognized Certification Body in many global markets
BSI understands the specific challenges medical device manufacturers face and the importance of bringing innovative yet safe products to global markets. Ensuring the predictability and transparency of regulatory product clearance is crucial to maintaining a competitive edge.
BSI demonstrates this commitment through:
- Over 2,050 years' medical device product and regulatory experience
- Internal Product Experts and Auditors
- Direct access to your team of technical specialists
- Our range of review services to give you flexibility
Find out more about BSI
CSA Group is an internationally accredited provider of testing and certification services and a global leader in healthcare systems conformity assessment services, helping manufacturers' access markets around the world. CSA test and certify medical products to required standards - including IEC 60601 and IEC 61010 - as well as offer cybersecurity assurance programs. For almost a century, CSA Group has helped clients demonstrate compliance with relevant standards for their products, helping them to reach patients and healthcare professionals around the world.
As a National Certification Body (NCB) in the IECEE CB Scheme, CSA Group is an expert source for testing & certification to IEC and ISO series of standards, including IEC 60601-1 (2nd, 3rd and 3.1 editions) series of medical standards.
CSA Group Tests and Certifies Electro-Medical Equipment and Systems Including:
- Cardiac Defibrillators
- CT Scanners
- High Frequency Surgical Equipment
- Homecare Products
- Lung Ventilators
- Magnetic Resonance Imaging (MRI)
- Nerve and Muscle Stimulators
- Operating Tables
- Therapy Equipment
- X-ray Generators
Find out more about CSA