How to determine regulatory requirements according to ISO 13485 Quality Management System for Medical Devices?

 

It doesn’t matter if organization has applied ISO 13485 or not, obeying with regulatory requirements is critical to production and service delivery in the medical device industry. If you want business to be successful, then need to understand the regulatory requirements that affect to product and service. Such regulations confirm the safety and efficiency of medical devices, and although some requirements may be seen as a burden, they really are in the best attention of both consumers and dealers.

Where do regulatory requirements come from?

ISO 13485 quality management system covers regulatory requirements in the same breath as consumer requirements right from the start. Clarification of Concept states: When the term regulatory requirements is used, it contains requirements confined in any law appropriate to the user of this International Standard. The request of the term ‘regulatory requirements’ is limited to requirements.

The purpose for this is the effect that regulatory requirements have on an organization’s ability to deliver its products or services. The ISO 13485 standard needs the organization to determine which regulatory requirements are relevant to its Quality Management System, and the effects they can have on the QMS. Regulatory bodies set requirements relating to several aspects of the medical device industry, with product and service provision, utilization of raw materials, communication with consumers, and other elements of an organization’s operations. An absence of compliance, whether knowingly or not, can result in serious consequences—not the minimum of which are expensive fines and injury or death to a patient.

Almost everybody in the industry understands the importance of these regulations, but it can sometimes be hard to identify all appropriate requirements. Generally, need to study the regulatory authorities in own country, as well as those in any other countries to which provide products or service. Let’s look in more detail at which groups need to pay attention to when trying to identify regulatory requirements:

Regulatory bodies: Every nation has a regulatory body that supervises the medical device industry. Organizations delivering medical device products or services must meet the requirements the FDA will cancel the organization’s license to work in the United States.

Acts: In some countries, Acts regulate the providing of medical devices and services. One such Directive is the European Commission’s Medical Device Directive, which sets requirements connected to expected levels of durability and performance in medical devices in Europe. Like the regulatory requirements mentioned above, there can be high costs related with failure to obey with Acts and Directives.

Medical device legal devices: Many countries have statutory instruments regulating the medical device industry. In Ireland, this is statutory instrument No. 252/1994 – European Communities Regulations, 1994, and all producers and suppliers of medical devices in Ireland must also obey with these requirements.

What is the connection between regulatory requirements and ISO 13485?

According to ISO 13485 certification, as with any other international standard, shows stakeholders and interested parties that an organization goes over and above appropriate legal requirements, holding itself to a higher standard. An organization cannot be obedient with the standard if it does not meet regulatory requirements.

ISO 13485 contains a handful of requirements that deal with the knowledge should have gained while identifying applicable regulatory requirements. After all, understand such requirements in order to carry out Quality Management System procedures correctly. Some of these requirements contain:

•     The QMS must contain the requirements for roles undertaken by the organization for applicable regulatory bodies.
•      Advisory notices must be made available to appropriate regulatory bodies.
•    Traceability of measurement must be maintained according to the needs of relevant regulatory bodies.
•     Requirements for products and services should contain requirements from applicable regulatory bodies.
•     The design and development process to consider the requirements of regulatory bodies, such as the level of control that is expected in the procedure.
•     Management review must contain reports to regulatory bodies as inputs and as outputs, any essential changes in response to new or changing problems with regard to relevant regulatory bodies.

An appropriately planned QMS contains relevant regulatory requirements:

The first step along path of ISO 13485 implementation, and becoming more competitive in market, is understanding and complying with regulatory requirements. By doing so, organization will be well equipped to deliver safe products and services, and prevent the problems related with noncompliance. The ISO 13485:2016 standard gives a solid foundation for identifying applicable regulatory requirements, and measuring organization’s level of obedience.