Medical device manufacturer, Bedfont Scientific Ltd., receives its ISO13485:2016 CMDCAS certificate
Established in 1976, Bedfont Scientific Limited is a second generation family company that has specialized in the design and manufacture of exhaled breath and gas monitoring instruments for medical, scientific and industrial markets globally, for over 40 years. Bedfont is thrilled to announce that it has just received the ISO13485:2016 CMDCAS certificate which is a re-certificate on the new standard, 2016.
The multi export award winning British company is revered as a pioneer in the breath analysis market with their products now available in over 76 countries. Without the ISO13485 CMDCAS certificate, it is impossible to enter the Canadian market and so this recertification enables Bedfont to continue exporting to Canada, with hopes to grow sales in this area by over 20% in the next 5 years.
Louise Bateman, QA & RA manager, explains:
The ISO13485:2016 is the best internationally accepted accreditation to show compliance to regulators for the medical device industry. It is an extremely important recognition to our company’s commitment to produce the highest quality standard of medical device to sell to our customers.
Jason Smith, Managing Director, adds:
For only a small company of 41 employees, to have exports account for roughly 80% of our annual turnover is a great achievement. We have a great RA team, led by Louise, who makes sure that, while we continue to innovate our products, they always remain at the highest standard for the medical device industry. Being such a niche manufacturer, and new MDDs, this no easy feat, but with dedication and support from all in the Bedfont family, I am proud that we have achieved the ISO13485:2016 CMDCAS certificate, making us eligible for the export awards we have won this year.