Why ISO 13485 Might Not Be Enough for Your Medical Device Manufacturing Process

ISO 13485 manufacturing is an established quality standard, pertaining to medical device manufacturers. However, as with any quality standard, it is more a set of general guidelines which every manufacturer applies to their own situation according to their status, infrastructure, and working conditions, rather than a recipe for success. There are multiple ways in which it can be applied to each manufacturer’s case, therefore making each medical device manufacturer responsible for guaranteeing their operational effectiveness and success, independent of their ISO 13485 manufacturing certification.

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An Overview Of ISO 13485 Manufacturing Quality Standard

First published in 1996, ISO 13485 in manufacturing is a voluntary quality standard issued by the International Organization for Standardization, as a comprehensive quality management system to be used by medical device manufacturers. It is widely considered as the preferred method for medical device manufacturing companies to document and prove compliance according to EU, US, and other jurisdictions regulatory standards.

Most important requirements of the ISO 13485 manufacturing quality standard, revolve around adhering to rules and maintaining sufficient documentation. Maintaining compliance of these requirements ensures the medical device manufacturer’s efficiency in the following areas:

  • Product safety by having work environment controls in place
  • Conduct proper risk management and design controls during new product development activities
  • Demonstrate compliance to mandatory regulatory requirements in their jurisdiction, such as those enforced by the U.S. Food and Drug Administration (US FDA 21 CFR, part 820) and the European Union (93/42/EEC directive)
  • Follow requirements pertaining to specialized cases, such as traceability for implant devices, process validation for sterile medical devices, and proper management of CAPA’s (Corrective And Preventive Actions)

The Meaning Of ISO 13485 Manufacturing

An ISO 13485 manufacturing certification, means the manufacturer covers the regulatory requirements as outlined above, and adheres to a broad set of rules and guidelines, regarding documenting, taking certain steps for medical device product development, as well as incorporating basic medical device safety standards. These guidelines provided by the standard do not force medical device manufacturers on how they can conduct business altogether.

Not all ISO 13485 certified medical device manufacturers are equal, just because they follow the same quality standard. For example, a medical device manufacturer can be fast, flexible, and provide comprehensive turnkey services, while another can be slow, rigid, and provide only part of the product development process, all the while both being ISO 13485 certified.

Beyond The Standard

Just as having a driver’s license does not mean every driver will behave identically as everyone else, same goes for the ISO 13485 quality standard certification. Every medical device manufacturer rolls out and implements the quality system’s requirements within their organization in their own unique way, which highly differentiates their effectiveness and level of service from other manufacturers.

Some very important factors that play a crucial role in making for a successful medical device manufacturer and are independent of the ISO 13485 certification are:
Knowledge of the medical devices market vertical: Manufacturer specialization exclusively in the medical devices market vertical, instead of coupling medical device development along with other types of similar equipment. This specialization is an important part of being knowledgeable in all details and aspects of each medical device sector, resulting in the efficient development of successful medical devices.
Deep manufacturing experience & infrastructure: An experienced medical device manufacturer is in a position to proactively help customers deal with the complexity of medical device development, saving up a lot of time, resources and cost, while contributing to making an optimized and efficient medical device.
Specialized management & workforce: The manufacturing of medical devices requires work to be conducted under very protected, specialized conditions, with extreme dexterity and precision. An effective medical device manufacturer employs experienced and specialized workforce, specifically trained to work on medical devices only. Moreover, all involved management and workforce throughout the development and manufacturing processes, should be highly trained and educated on all GMP regulations, standards and practices.
Providing comprehensive, turnkey solutions: An efficient manufacturer should provide complete services for every part of a medical device product’s lifecycle. This includes all stages of product development, as well as prototyping and mass manufacturing, saving up on costly and time consuming transitioning between separate collaborating companies, as well as having a clear product development and manufacturing roadmap from beginning to end.

Gain A Competitive Edge with Quasar

Quasar is ISO 13485 manufacturing certified, and consistently demonstrates its stellar quality of services with world class regulatory bodies such as the US FDA. Consecutive results of zero observations of the FDA Form 483 stand as a testament to Quasar’s impeccably high standard. Quasar has over 30 years of experience in the development and manufacturing of medical devices.

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