ISO 13485:2016 Medical Devices Quality Management System (MDQMS)

WHAT IS ISO 13485?

ISO 13485:2016 is the most extensively used and most preferred Quality Management System in the medical industry

Risk management operations include identification, evaluation and prioritization of threats

ISO 13485:2016 insists the companies to define requirements and budgets, perform design reviews, risk analysis, verification protocols and more.

It is considered as a dynamic tool owing to the fact that it gives a framework that is compatible with every business yet is flexible to the unique characteristics of each business.


  • A medical device is any instrument that is intended for medical purposes such as diagnosing and treating patients, helping them to subdue illness or disease. There are potential hazards connected with the use of medical devices and so these products must be shown to be safe and effective with regulations
  • The company staff has to write down information for each product, for example, device’s function, performance, etc. It’s very pricey to learn that a key feature of your product has gone missing, right after committing a design to another company. By tracking and documenting each feature, performance and so forth, you are made to completely think about every element of your product


ISO 13485:2016 sets prerequisites, policies and instructions for any business thatdesigns, manufactures, assembles, stores, installs, distributes or services medical devices. This includes agencies that provide related assistance or components at any stage which incorporates technical support, distributors and external third parties.

The rewards of implementing ISO 13485 can't be overstated. Companies of all sizes have gained huge savings in expenses and time, in addition to other enhancements that an effective Quality Management System naturally brings about. Medical device businesses that market their products internationally will benefit most as it reduces trade barrier to enter the international market.


  • Certain countries such as the USA, Australia, Japan, Canada, Europe demand that medical devices must be ISO certified. Yielding to ISO 13485 standard is a requirement for medical businesses seeking access to new markets.
  • Pleases potential customers & stakeholders with the fact that a product has been produced with compliance to an internationally recognized standard. It boosts your customer’s trust in your business as a safe choice.
  • Improved documentation and control of processes leads to stability in performance, and less scrap and rework. It minimizes production loss rate, operational expenses and hazards. You can identify and eliminate waste in between processes and avoid errors.
  • Have complete insight in your overall processes, and any improvements that are brought into
  • ISO 13485:2016 highlights audit activities, management review and fine-tuning of processes based on collected information. After analysing facts, improvements are planned and implemented carefully. This makes certain that the best decisions are drafted for your business, resulting in better operations, performance and profitability.