Product approval of medical devices
Get help with approval of your medical devices – legal requirements apply from the beginning of the development phase.
As a manufacturer of medical devices, you are met with many requirements and comprehensive regulation
It is a determining factor that you begin the process correctly and consider legal requirements for product and quality management, from the beginning of the development phase. To be able to meet the different test standards within EN 60601 or IEC 60601 family, you must be able to document product development according to standardized risk management in accordance with ISO 14971. Moreover, a number of supplementary tests are required: software, usability, mechanical and climatic, and of course EMC and safety.Why let FORCE Technology be in charge of the approval of medical devices?
We have many years of experience in testing and approval of medical devices, and we can guide you through the entire process. We are specialized in testing of medical devices within technical disciplines such as medico-EMC, safety, and reliability, including the required risk management system. Further, we are experienced in working in the cross field between medical devices and wireless devices, thus obtaining maximum synergy between the two worlds with considerable cost and time savings as a positive result.We will be pleased to include new specific standards in our scope on request, enabling us to deliver accredited and CB Scheme certified as usual.
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Complete product approval
As Denmark’s largest all-in-one test house, we offer to take care of all product approval process.
Get accredited product certification by a notified body
Certification is mandatory for certain approvals or as proof of a product's conformity.
Extreme test for harsh environments
Our extreme and special test provides evidence of the product's resistance to harsh environments.
Electrical safety test
There are legal requirements to ensure that electrical and electronic products are safe in use.
EMC test
The ability to co-exist with other electronic equipment is key to product approval.
Approval requirements for products
Clarification of requirements to ensure that products are compliant, labelled and marketed.
Climatic test
Get documentation demonstrating that your product can withstand real life conditions.
Mechanical tests - Vibration, shock, impact and drop
Document that your product can withstand the conditions it will be exposed to during normal use.
Technical audiology
Audiological tests on hearing aids and certification of Danish hearing clinics.
Technical guidance and EMC consultancy
Do you need engineering services and problem solving of the highest standard?
Wireless approval and performance test
Do your wireless products and systems comply with all requirements?