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.
