ISO 13485 – The Needs and Costs

Why ISO 13485?
Suppose you are a manufacturer of medical devices, irrespective of where you are in the supply chain. In that case, it’s critical to stick to the required rules and controls to ensure product safety for end-users. However, with quality criteria for products fluctuating from one country to another, it cannot be easy to systematize these regulations. This is where ISO 13485 Medical Devices becomes a rescue.

This globally-accepted ISO standard renders rigorous guidelines for manufacturers and distributors of medical devices. This standardization facilitates a globally-recognized level of quality and compatibility for all devices and similar products.

Who Requires the ISO 13485 Certification?
The ISO 13485 certification is designed for any firm that designs, produces, distributes, implements, or offers services of medical devices. Organizations that fabricate materials for medical devices must also obtain accreditation of this standard before their products can be utilized in the medical profession.

A medical device indicates any sized instrument, machine, implant, or in vitro device (IVD), as long as it is reserved for medical purposes. These devices assist in the diagnosis, prevention, or treatment of illnesses. This is why it becomes immensely critical to regulate the diverse rules encompassing the quality management of such devices.

Is this Certification A Legal Obligation?
The ISO 13485 Medical Devices standard is not enforceable by law. Nevertheless, many governments worldwide usually make it a legal requirement for corporations to adhere to the Medical Devices Directive (MDD). This doesn’t inevitably need accreditation to ISO 13485, although many manufacturers favor this set of standards because they are in tune with the MDD. Many businesses implement ISO 13485 as a compulsory and required method within their own companies and to their suppliers.

In a few countries, the governing provisions for medical devices are not as stringent as those set out in the ISO standard. This essentially means that manufacturers or suppliers who are not accredited to the ISO 13485 would not be able to trade with companies that enforce these standards. However, there are a few expectations.

What are the Associated Costs?
The total cost of ISO 13485 certification changes based on several parameters, such as:

  • The quantity of units and nature of the medical device
  • The manufacturing plant or facility’s floor area
  • The number of employees and agents in the company
  • The sanctioned body that will administer the inspection and provide certification

While one might feel that all of this may concur to a considerable upfront cost, obtaining accreditation to this ISO 13485 standard for medical devices will help you save money in the long run. The reason behind this is that the standards will require you to optimize your manufacturing and production processes, driving highly minimized operating costs and a more streamlined manufacturing process. Possessing this accreditation also broadens the scope for your business, enabling and empowering you to aim for new clients, fresh models of business, and healthy new industries.