Elexes often provide start-to-finish regulatory and quality services to clients. One such example is a start-up that was developing a novel wearable device to monitor vital signs.The company needed regulatory approval in Australia, the US, Canada and Europe.
With our project management skills and thorough knowledge of regulations, we broke down the entire project into several major milestones.
For bringing any product to a country’s market, there are FOUR important things to always keep in mind –
1) Meeting applicable regulatory requirements of that country.
2) Having a robust quality system with all associated documents in place.
3) Executing the right testing to support the product’s safety and efficacy.
4) Obtaining regulatory approval of the country.
Based on a thorough analysis and prior experience with wearables, we defined all requirements for each of the countries at the beginning of the project. This gave our client clarity as to what it will take to bring their device to the respective markets. Once market-specific requirements were defined, Elexes defined action items to fulfill each and every requirement and supported the clients in executing the action items. Some of the action items were – procuring RoHS certifications from component suppliers to fulfill the RoHS requirement, getting FCC certification to fulfill the Bluetooth safety requirement, obtaining IEC 62133 compliance for battery safety, ensuring bio-compatibility for all patient contacting materials, and electrical safety for all electrical components.
Parallelly, Elexes experts created quality systems documents, including design control like the system requirements specifications, design input, design output, and traceability matrix. Testing required to launch the product in Australian, Canadian, European and US markets were defined and presented to the client with rationale. After Elexes and the client were on the same page in terms of testing, Elexes leveraged its relationships with test labs to execute testing. We ensured that the testing was done in accordance to applicable regulations and standards like the IEC 60601, ISO 10993, and ISO 11607.
Aiming for quick deliverance, the sections of the submissions that were independent of test results, like the cover letter, device description, and manufacturing flow chart were prepared early on. After the test results were acquired,Elexes prepared all test dependent sections of submissions within 2 weeks and sent over the submissions to the Australian TGA, Health Canada, US FDA and European Notified Body for review.
Elexes then, corresponded with regulatory bodies and ensured successful clearance of the product for the client.