Ensuring market access for sustainable and safe medical devices
Most MedTech and welfare tech companies face challenges when implementing new technological and sustainable solutions, when compliance with standards, regulations and consumer safety remain the highest priorities.
Time-to-market is a challenge for MedTech and welfare tech products
Time-to-market is crucial for the competitiveness of companies producing devices, products, or equipment within MedTech and welfare. Short R&D cycles, rapidly evolving technology, growing risk awareness and increased user involvement all contribute to the need for more innovative use of technology to ensure fast launches of products. And when it comes to connected devices, e.g., remote monitoring or app-based solutions, cyber security is key.
But, in a heavily regulated industry such as MedTech and welfare tech, it can be challenging to implement new technological and sustainable solutions when compliance with standards, regulations and consumer safety remain the highest priorities.
An easy and safe way to customers and end users
That is why we strive to make innovation, development, test and launch of new medical devices and equipment easy and safe. To do this, we apply our impartiality and technological expertise, combined with regulatory knowledge and active participation in standardisation committees, and we ensure access to a wide range of testing facilities.
Shorter time-to-market without compromising quality
We ensure market access through:
Product approval of medical devices
Ensure your medical device’s compliance with regulatory requirements, such as MDR, already in the RnD phase.
Chemical test of equipment, incl. PPE
Testing and approval for importers, manufacturers and distributors that documents your product’s compliance with existing market standards.
Life cycle assessment (LCA) of products
Life Cycle Assessment makes it possible for you to document and explain how your product or service impacts the environment.Cases
From single test to dedicated partnership with WSA
/Case
Hearing aid giant gets documentation for compliance with new regulations and market requirements.
Dansac improves their quality assurance competencies
/Case
The medical device company Dansac found a shortcut to increase their competencies in assurance.
Knowledge of standards future-proofs medical devices
/Case
XO CARE uses knowledge about standards actively to future-proof their dental products.
Learn more about safe and sustainable medical devices
Green design of medical devices
/Article
IoT as driver for a digital health sector
/Article
IoT will affect our health sector. This requires focus on responsible design and reliability.
Risk and safety management for medical devices
/Article
How to handle risk and safety management when you develop medico devices.
Healthcare and the Internet of Things
/Article
Remote monitoring in the healthcare sector requires interoperability of healthcare data on electronic platforms.
