The teams from efsg2
With their recent graduation from Entrepreneur First Singapore's 2nd cohort, we are extremely happy to support them in their compliance journey (which we will feature them in subsequent blog posts to showcase their journey towards ISO certifications). In this cohort, there are SIX medical devices start-ups - each having an innovative product that's pushing healthcare frontiers.
At Stendard, we simplify compliance for all businesses. With this vision, we constantly support companies way beyond document generation. In all compliance journey, the final step is always the most challenging and companies usually do not know what to expect at the finale!
In order to let the teams be familiarised with their auditors and certification bodies, we had the privilege to organise a quick orientation with key representatives from the top 3 Certification Bodies in Singapore - namely TÜV Rheinland, SGS and TÜV SÜD PSB.
The finale - ISO 13485:2016
It was an interactive session with many great questions posed to the certification bodies regarding the types of services they can receive besides certification and testing.
One particularly striking topic is the applicability of ISO 13485 to standalone medical device software, as well as how the controls of outsourced process such as cloud-services and servers shall be managed. With technology advancing at such a speed, and with better and greater number of healthcare/medical products emerging, clarification towards such topic is definitely required.
With more companies focusing on telehealth, apps and medical device software, there is a constant growing need in implementing IEC 62304 requirements within the company's processes.
What is IEC 62304?
In the coming weeks, we will also be announcing how Stendard is expanding our support for software-centric companies and to help them deal with their ISO 13485 implementation, with special focus on IEC 62304.
This is going to be exciting, so watch this space!