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How to Implement QMS for Medical Device Startup?

calendar17 Feb, 2023
timeReading Time: 4 Minutes
How to Implement QMS for Medical Device Startup?

QMS stands for Quality Management System, is an organized system consisting of method and actions that includes Supplier management, Risk management, Designing, Manufacturing, Handling clinical data, Production, Cost Management, Construction, Customer feedback, Dealing with complaints, Distribution, Marketing, Labeling etc. Medical device industry is growing and gaining huge awareness. It is a constructive management system that helps to establish all the methods and procedures that are required in the whole life cycle of a medical device. Quality management system (QMS) is measured differently in terms of different devices. It depends on the classification of the devices, such as companies manufacturing devices of Class I (i.e., Low risk device, non-sterile, non-measuring, non-reusable, surgical instrument devices) will have different perpetration than companies manufacturing High-risk devices (Class III) or Medium devices (Class II). In this article, we will discuss more about QMS for Medical Device Startup

Regulation Needed In The Case Of A QMS for Medical Device Startup

The mandatory requirement in the case of QMS for Medical device Startup is to obtain an ISO 13485[1]. It is a quality measuring certificate which is mainly designed for the companies and organizations that deal in production, manufacturing, installation and servicing of medical devices and other related services. ISO 13485 was made to reinforce manufacturers in the medical sector to build a QMS that governs and maintains the quality and efficiency of their operations. A medical device company must acquire ISO 13485 to meet all the standards for Quality Management System. 

Importance of Implementing a Good Quality Management System

You need to understand why it is so essential to implement a Quality Management System that meets the standards of ISO 13485.

Executing a QMS for Medical device Startup and preserving it is an important task in itself for regulatory compliance in most of the Global markets. In the case of a Medical devices start-up implementing a Quality Management System (QMS) assures that the product is safe and trustworthy, it also helps to deliver the right product to the right customer.  In order to maintain and administer a QMS, a startup requires manufacturers equipped with technical skills. To build a successful medical startup the main classified ingredient is to focus on implementation and practice and have good control over administration processes. It is always important to keep in mind a good quality system that circumscribes a good company. Acquiring a QMS helps to attract Global clients and make better business relationships with other countries.

Essential Ingredients of QMS for Medical Device Startup

The basic requirement for QMS for Medical Device Startup are as follows:

  • Document Control: The basic and the main requirement of a quality management system for medical devices is to have a complete control over documentation process, to be aware of its quality, the work plan and to meet deadlines for its compliances and  audit. Thus, it is very much important to have a rule book with all sections mentioned relating to ISO standards (i.e., ISO 13485) and understanding its mechanism.
  • Trained Personnel: In order to ensure that the quality management system functions effectively, Competent and experienced employees are required to maintain the quality standard and regulations such as in case of ISO 13485.
  • Governance of Auditory compliance: Manufacturer of medical devices must build up a proper audit team to carry out the operations and processes smoothly in accordance with periodic quality audit compliant to ISO 13485: 2016.
  • CAPA Management: CAPA stands for Corrective and Preventive Actions. This mechanism is used by the medical device manufacturer, to provide some corrective measures to combat regulatory compliances and risk. It ensures prevention of an extensive Quality Management System. For example, when there is a defect found in the case of manufacturing experts initially tries to detect the nonconformance and then find the ground cause of the problem. Thus, in order to initiate a proper Quality Management System (QMS) in any medical device, the CAPA management software plays a very vital role.

In order to meet all the QMS levels for medical devices, it is pertinent that one should possess ISO 13485:2016 certificate.

Advantages of Implementing QMS for Medical Device Startup

Following are the advantages of Implementing QMS for Medical Device Startup:

  • Use of QMS helps to impoverish product quality and entrepreneurial management system;
  • The more effective the Quality Management System, the faster cycle  of perpetration is;
  • There is a higher chance of customer satisfaction and increased market value with a better QMS system for medical devices;
  • With a streamlined QMS strategy one can minimize waste management, enhance supplier relationships and upgrade product quality.

Procedure of Implementation of Quality Management System (QMS) for Medical Device

The important phases of QMS for medical devices covers aspects such as Manufacturing, Recording Clinical data, managing of Regulatory risk, Labeling of product, Design, Supply Chain management, Distribution, Production data handling, Complaint handling, Customer feedback, documenting nonconformance of product. The more tranquil the Quality Management system (QMS) will be, the more effective will be the working of the Medical Device startup. The intricacy of the QMS program depends on the diversification of the devices. Suppose, the Medical Device startup is making Medium-risk to High-risk devices then it will require a different setup of QMS for its implementation, than the manufacturers producing Low-risk non-sterile surgical devices.

  • The first step of QMS implementation includes analyzing potential and skilled staff who can provide endurance, meet deadlines and have the ability to support the administrative work as well.
  • The second step entails the training of the members of the organization, who need to be educated about the ISO standards and set of rules and requisites and make them aware about the process of QMS.
  • It is essential to conduct comprehensive research of the present situation of the company either in the form of a questionnaire or survey or interviews.
  • The fourth step contains an implementation of documentation. In this step, all the organization process and administrative works must be outlined and documented well, in order to meet the required ISO 9001:2008 general standards.
  • The fifth step includes conduct of internal audit checks in the process of the Quality Management System of a healthcare startup. This step ensures to accomplish an organizational objective by building a systematized, structured approach in order to maintain the efficacy of the institutional growth, mitigate risks and administer governance. Thus a proper quality audit check helps to ensure the company is in accordance with all the regulatory risks and compliances, upgradation of documents, proper controls over the administration and assess the organization’s internal functions.


To sum up, it is the basic condition for any medical device industry, to maintain a Quality Management System (QMS) for its product attainment. All the new manufacturers in the Healthcare industry producing medical devices must implement a Quality Management System (QMS) at the early stage that helps to assure that a particular medical device business has all the framework setup right from mitigating risk to manufacturing of quality products and vendor and supply management. This helps to attain international clients and contributes towards the growth of the company. A well-defined quality management system develops consistency in the organization.

Read Our Article: A Step By Step Guide For Registration Process For Medical Devices In India

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