Through MDSAP (Medical Device Single Audit) certificate, the companies are able to indicate they operate according to ISO 13485:2016 -standard and regulatory requirements set by Australia, Brazil, Canada, Japan and USA.
“At Innokas Medical, everything begins with the quality built into our processes, products and services. All this can be seen through the high-quality daily work at Innokas. When our employees are following Innokas Medical procedures, the requirements are fulfilled throughout the device whole life cycle”, tells Tiina Kotipalo, Head of QA&RA at Innokas Medical.
The realization of all this in practice has been audited at Innokas by many of Innokas’ customers and Certification Bodies during the past year. The latest audit was conducted by SGS Fimko.
”The latest audit lasted 7 days and it was part of the MDSAP -program. During the audit, the Certification Body inspect how Innokas’ functions correspond to ISO 13485 Quality Management System, Medical Device Directive MDD and Medical Device Single Audit Program MDSAP including Canada requirements. The Certification Body audited our all sites in Kempele, Espoo, Helsinki and Tallinn”, Kotipalo explains.
Innokas Medical started to transfer to MDSAP -program in 2019 by necessary quality management system updates. The first audit in MDSAP program was conducted last year, after which Innokas was granted with MDSAP certificate.
“In autumn 2019 the first audit of the MDSAP program was conducted at Innokas, and the most recent one was the first surveillance audit. The next audit will be conducted again next year by SGS Fimko”, Kotipalo tells and continues:
“The auditing program of MDSAP is accurate as auditors inspect companies through a well-defined task-based approach. The result of the audit at Innokas was very good as we got only few minor findings. We've already started to implement the corrective actions. Additionally, we got lot of good feedback from the auditors; our Quality Management System was said to be excellent, personnel competent and the tools, especially on the design and development side, was said to be efficient. Additionally, our manufacturing was found very professional and to be in good control. Thanks for the excellent results like this belong to all Innokas employees!”
In addition to own personnel, Kotipalo would like to thank SGS Fimko as professional Certification Body.
“The suitability of our quality management system was verified with solid expertise by several experienced and trained auditors”, she praises.
The audits conducted in the MDSAP -program are currently required only by Health Canada. However, these audits have also been recognized by several other regulators. This means that through MDSAP certificate, the companies are able to demonstrate organization’s quality management system will satisfy the requirements of the medical device regulatory authorities participating in the MDSAP program. The MDSAP members are at the moment: Therapeutic Goods Administration of Australia, Brazil’s Agência Nacional de Vigilância Sanitária, Health Canada, Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency and U.S. Food and Drug Administration.
“As an example, FDA's Centre for Devices and Radiological Health (CDRH), who is responsible for regulating companies who manufacture, repackage, relabel, and import medical devices sold in the US, accept MDSAP audit reports as a substitute for routine Agency inspections”, Kotipalo explains.
At Innokas Medical, the regulatory requirements of Canadian authorities have been built in the company’s processes and practices already earlier as Innokas had CMDCAS 13485 certificate before the MDSAP one. CMDCAS certificate was required from medical device manufacturers and distributors before they were able to sell and market their medical devices in Canada. Now the certificate is been replaced with MDSAP certificate, which was granted for Innokas early this year. Additionally, Innokas has ISO 13485:2016 certificate for design and manufacture of medical devices, and all of the company’s sites have FDA registration as well.
“These certificates are essential for Innokas to be able to convince our customers and regulatory authorities that Innokas is capable to design and manufacture medical devices to the worldwide market”, Kotipalo concludes.
For more information, please contact:
Tiina Kotipalo | Head of QA&RA | Innokas Medical Ltd.: tiina.kotipalo@innokasmedical.fi