Being the manufacturers of a medical device, it is your core responsibility to ensure that your medical product conformity is secured. ISO 13485 and Food Drug Authority (FDA) can be of great help when it comes to building a strong structure for QMS (Quality Management System). Products and processes should be made on the foundation of concrete specifications and strict quality control to make sure all the requirements are fulfilled or to note and investigate any deviation.

The good news is that if any company successfully meets all the requirements of ISO 13485:2016 then it can easily satisfy all the requirements. ISO 13485 is an ISO standard that is mostly based on the same foundation of ISO 9001:2008 but ISO 13485 is specific to medical device industries and it is soon to be adopted by FDA probably by April 2019. Meeting quality objective system should be one of the main goals of medical device industries. However, there are few medical devices that the FDA has decided to exempt from certain GMP (Good Manufacturing Practices) requirements.

Comparative Analysis

ISO 13485 and FDA has various similarities and point of differences also which are elaborated below:

Documentation System

ISO 13485 is an ISO standard that requires a compulsory system for QMS. FDA also does not require organizations to fulfill any specific documentation system.

Fulfilments of the Requirements

All the requirements fulfillment of ISO 13485 is called conformance whereas all the requirements of FDA are called compliance so conformance to ISO 13485 is done to satisfy customers/consumers and compliance with FDA is an imposition by US government.

Management Reviews

Both management systems have mandatory requirement to conduct periodic management review meetings so that accomplishment of the quality objectives are ensured.

ISO 13485 requires the input of periodic management reviews in the form of outcomes of audits (internal or external), the status of CAPA, feedback or any complaints from customers any revision or amendments made to the management systems needs to go through proper change management.

Customer Centric

ISO 13485 is more customer focused as compared to FDA because FDA focuses on the fulfillment of rules and regulation first. ISO 13485 refers to the fulfillment of requirements so that customers’ satisfaction can be achieved throughout the complete life cycle of the products.

Infrastructure and Resources’ Distribution

With respect to resources’ distribution and infrastructure, the FDA tends to focus more as compared to ISO 13485. FDA specifies the training needs of medical staff especially during validation and verification needs. They also has requirements for equipment’s maintenance schedules, periodic inspections, adjustments (if required) and manufacturing materials used to produce medical devices.

Design and Development of Products

ISO 13485 focuses on design control of medical devices whereas FDA focuses on controlling medical devices, especially that lies in high-risk devices involving Class II, Class III and few of the Class I devices. Both ISO 13485 and FDA has a consistent set of objectives when it comes to the design and development of medical devices, medical outputs, validation, verification, and reviews.

Process Control Parameters

Both methodologies specifies parameters of production processes but FDA somehow emphasizes more process parameters like labeling products, storage, and preservation of the products, packaging of the product, product handling and distribution, change management especially in manufacturing process parameters. Moreover, in case of any deviations, the Food and Drug Administration specifies the counter steps that can be taken to cope with such production process deviation.

Improvement in Management System

Both emphasize on continuously improving the management system by taking corrective and preventive actions known as CAPA. As far as customers’ complaints handling is concerned, both FDA regulations and ISO 13485 have specific requirements regarding complaints’ handling.

Medical Devices’ Trace Ability

Medical devices including surgical implant devices have trace ability requirements as the mandatory requirements of ISO 13485 and FDA. Manufacturers need to determine up to which level they will be needing traceability of the medical devices.

The quality management system of the Food and Drug Administration is more synchronized with ISO 13485 as compared to ISO 9001:2015. That’s why when it comes to medical devices’ industries, most countries are dependent on ISO 13485:2016. The role of the Food and Drug Administration cannot be neglected when it comes to the revision of ISO 13485:2016 because companies will be easier to implement that management system which is being followed in more than one companies.

Can Medical Devices’ Manufacturers use ISO 13485:2016 for FDA Compliance?

Due to many similarities found between ISO 13485 and FDA regulations, many companies tend to use ISO 13485 as compliance for FDA in order to meet common points of requirements present in both the management systems. ISO 13485 provides a concrete foundation to satisfy FDA part 820 requirements along with some additional requirements of various regulatory bodies being followed in the world.

However, there are few requirements mentioned in the FDA that are not being fulfilled in ISO 13485. Therefore, there is a dire need to outsource an ISO consultant that can perform gap analysis effectively between ISO 13485 and FDA regulatory requirements so that an organization can be compliant with both the management systems. The Food and Drug Administration has worked in full collaboration with other members of ISO to craft the latest version of ISO 13485 and ISO 13485 did not fully influence Food and Drug Administration regulatory requirements.

Both the systems, ISO 13485 and FDA regulations are not basically different or unrelated. Usually, the medical companies if compliant to one system feel rather comfortable in fulfilling other system’s requirements too but it differs from region to region.

FDA regulation is in the spotlight in the US. On the other hand, medical devices’ industries in Canada, Japan, Australia, New Zealand, and EU religiously follow ISO 13485. Countries other than the specified countries usually implement and follow on just the ISO 13485 standard or the Food and Drug Administration or both the systems whichever suits than best or whatever they feel easy to implement, easy to train employees keeping their current competency level in view and easiness in following it effectively and efficiently.

Wondering where the Gaps are in your ISO Certification Or CMMI Appraisal plans?

Your Free High Level Gap Assessment Report provides a bird’s eye view of the gaps in your business processes and what you can do to fill them

founder of sync resource

About Author

Sunita Verma, Founder and President of Sync Resource started the company in 2009 with a vision to provide management consulting to small & medium size businesses around the country.
Sunita holds a Master’s Degree in Mechanical Engineering from Cleveland State University, Cleveland, Ohio, Bachelors in Mechanical Engineering(India) with prestigious gold medal by then President of India and renowned Scientist Dr. A.P.J. Abdul Kalam.
As an active philanthropist she believes in pay it forward and is a contributing member of charitable organizations like St. Jude’s Foundation and North Fulton Charities.


You May Also Like…