ISO 13485 – Insight into QMS Standard for Medical Devices

The latest version of ISO 13485 primarily emphasizes regulatory compliance. For an organization seeking to show compliance to ISO 13485, it must meet all the standard’s applicable regulatory requirements. Therefore, it is important for both medical device manufacturing companies and medical start-ups to understand this standard’s regulatory requirements.

The Quality Management System (QMS) of ISO 13485:2016 interacts with both regulators and customers. It helps in keeping both of them in touch as it puts its focus on

  • Product realization and feedback;
  • Measurement;
  • Analysis, and
  • Improvement.

What are Regulatory Requirements as per ISO 13485:2016?

According to ISO 13485:2016, regulatory requirements given in the standard are

  • Applicable laws;
  • Regulations;
  • Ordinances and/or
  • Directives.

These regulations are formulated and laid down by different regulatory bodies. While devising these standards, these regulatory bodies keep different aspects of the medical device industry in mind, such as

  • Focus on product safety;
  • Service provision;
  • Raw materials’ consumption;
  • Customer communication;
  • Communication with regulatory authorities, and
  • Other manufacturing operations.

Different Entities According to ISO 13485:2016

According to ISO 13485, countries have some entities which govern the process of formulating regulations.

Regulatory Authorities

Every country has regulatory authority for the regulation of the medical device industry such as

  • FDA in USA, and
  • EMA in Europe.

Directives or Acts

In some countries, the supply of medical device and related services is directed by several Directives or Acts such as:

  • Council Directive 93/42/EEC, which is the European Commission’s Medical Directive. It provides requirements that are needed to provide durability and quality performance in medical devices.
  • FDA 21 CFR Part 820, which is a regulation in the U.S.

Statutory Instruments

In some countries, statutory instruments manage the medical device industry. For example, Statutory Instrument No 252/1994, European Communities regulates medical device producers and providers of Ireland to comply with its requirements.

The Relation between Regulatory Requirements & ISO 13485

According to ISO 13485, an organization can either meet or exceed all regulatory requirements. Therefore if the organization wants to show compliance, it must fulfill all regulatory requirements of the standard. Some specific requirements of ISO 13485 deal with the manufacturer’s existing knowledge, which he acquires while determining the relevant regulatory requirements. Comprehending these requirements altogether is essential for QMS process management.

Clauses of ISO 13485 Regarding Management of Regulatory Requirements

Medical Device Classification Process of FDA

According to FDA, medical devices are classified into three different classes. These classes (Class I, Class II, and Class III) are governed by some control measures.

According to the above illustration:

  • General Controls regulate all three classes, i.e., Class I, Class II, and Class III of the medical devices. Class I medical devices get market approval after getting regulated by General Controls.
  • Special Controls regulate Class II and Class III of medical devices. Class II medical devices get market approval after getting regulated by Special Controls.
  • Additional Clinical Data and Pre-market Approval (PMA) is required for regulating Class III medical devices before granting them market approval.

Choose TSQ Asia and the Middle East for your QMS Requirements

Showing compliance to regulatory requirements assists a medical device manufacturer in approaching the market. By showing compliance, he can ensure his products’ safety while avoiding any potential setbacks due to non-compliance at the same time.

TSQ Asia and the Middle East are helping medical device manufacturers with an FDA-compliant medical device QMS. With our help, manufacturers can ensure their compliance with the FDA and market their products worldwide. We offer our expertise to medical device manufacturers, medical device software developers, and Software as Medical Devices (SaMDs). If you are a medical device manufacturer looking forward to incorporating an FDA-compliant QMS, contact TSQ Asia & Middle East. Just give us a call at +39 351 516 9734 or visit us at our website


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