Methodize provides due diligence auditing services to firms considering a merger with, or acquisition of, a medical device company. Many clients ask us to perform these audits as a means of ensuring the target company will be able to maintain quality assurance and regulatory compliance in all markets where the device is sold or used.

We specialize in helping medical device companies comply with international regulations. As a result, we are extremely familiar with the following medical device regulations and can perform audits to determine the extent of compliance with:

  • USA – US Food and Drug Administration regulations 21CFR PART 820
  • EUROPE – Medical Devices Directives/In Vitro and CE Marking per MDD 93/42/EEC (and its amendments)
  • JAPAN – Pharmaceutical and Medical Device Act (PMD Act)
  • CANADA – Medical Device Regulations (CMDR SQR 98-242)
  • AUSTRALIA – Therapeutic Goods Act (TGA)
  • CHINA – CFDA Regulations for Medical Devices

    Compliance with Quality Management
    Device clearances/approvals are important, but once these have been achieved, some companies are much better at maintaining regulatory compliance than others. While a company may have ISO 13485 certification now, future compliance is not a given (particularly with the ISO 13485:2016 looming). Compliance with the US Quality System Regulation (QSR/ FDA 21 cfr part 820) is even more difficult to measure since the FDA does not certify the quality system of medical device companies.
    Methodize has extensive experience with US and international regulations, so we can perform an audit on your behalf to determine the target company’s level of compliance with the following quality system standards and regulations. As part of that process, we will evaluate the company’s Quality Manual and Standard Operating Procedures to ensure that applicable regulatory elements are established, implemented, and are being followed in markets where products are being sold.

  • ISO 13485:2003 as well as ISO 13485:2016 – Review of QMS to evaluate current status and likelihood of maintaining certification. This includes a review of compliance with the additional QMS requirements imposed by Europe, Canada and Australia, if applicable.
  • US Quality System Regulation – This comprehensive review of compliance with 21 CFR Part 820 will identify potential areas of concern if the FDA were to conduct an on-site inspection in the near term.
  • Japan Ministerial Ordinance #169 – This is Japan’s quality system regulation, which is based on ISO 13485 with additional requirements. If the company is selling in Japan, we will analyze their QMS to evaluate compliance with Japanese requirements.

Product and Process Compliance

Methodize also commonly performs audits to ascertain the level of compliance with other international requirements. These can include a review and analysis of:

•US FDA Design History Files, 510(k) submissions, Investigational Device Exemptions (IDE) and Pre-Market Approvals (PMA).

•European, Health Canada or Australian Technical Files or Design Dossiers.

•Canadian, Japanese and Chinese licenses.

•Complaint handling system, including MDR, MPR and Vigilance reports, to ensure a functioning process exists for regulatory reporting to government agencies.

•Past inspection reports (if applicable) from the US FDA, Japanese PMDA and Notified Bodies/Registrars.

•Corrective And Preventive Actions (CAPA) process to analyze the “time to closure” of complaints/incidents and verify if complaint trends are correctly entered into the CAPA system and addressed accordingly.

•Device labeling reviews to ensure compliance with applicable international regulations.

•Management review meeting minutes to determine level of management involvement in quality and regulatory compliance.

•Efficacy of post-marketing surveillance procedures.

Methodize can fully customize an audit to meet your specific needs. We recognize that such audits are often sensitive to the employees of the company being audited. You can be assured that our auditing team will perform their work discreetly and professionally, focusing only on the task at hand.

ISO 13485 and FDA 21 CFR PART 820]
Jack Slovick President Methodize Inc P.O. Box 463 Nevis, MN 56467 763.639.0238 (cell) www.methodizeinc.com