RE:newsAttached is a news release. Here is some background:
1. All medical devices have to be cleared, licensed, certified..lots of different “words” for regulatory approvals to sell the device in different countries.
2. The company has these approvals in Canada, USA, Europe and China, but still needs to maintain a comprehensive Quality Assurance System (QAS), which is audited regularly.
3. In addition, we have established our own manufacturing facility for the VMS+3.0 and that too has been inspected every 3 months for a year to make sure it is being run in accordance with North American regulations. Since we have passed all 4 inspections this year, we can go to less frequent inspections in the future.
4. The regulations also evolve over so we must also change how we do things to remain compliant.
5. It is a lot of paperwork and training of staff to remain in compliance with all the regulations, but it is necessary to maintain our approvals as well as to maintain the safety and quality of our products.
6. The recent QAS audit was a comprehensive one with a complete review of our technical file in Europe. It took many months to complete, but it is now not needed again for some years.
7. I have elected to tell you all about these successful audits so you will understand how hard the team is working and how successful it has been maintaining our status in spite of working from home and COVID limitations.
Thank you for your interest and support as we continue our mission to improve cardiac diagnostics and care world-wide for everyone and especially for children.
Regards,
Dr. George Adams ICD.D
Executive-Chairman