MDR Gap Analysis for Combination Medical Product

Organizing and running a medical devices business is a challenging task as compared to just getting up just as starter. It requires sufficiency and an efficient management to turn it into a successful one. Managing a business requires number of tasks to be done. They include planning of certain things, their accurate execution, and maintenance of several operations. One of the concerns, in running a medical devices business, is its proper management, and one of the important of its parts is compliance to applicable regulations and getting updated with the new updates. So if you have combination medical devices in Europe, you need to consider getting gap analysis done against the new EU MDR and remediation of your combination medical devices.

Combination Medical Devices

A combination medical device is a therapeutic as well as a diagnostic (a drug-device combination product). In a combination medical device, the device and drug form an integral part of each other, are always given in combination and cannot be reused. Examples of combination medical devices include:

  • Metered-dose inhalers
  • Pre-filled syringes
  • Fibrinogen and thrombin coated matrix (otherwise known as sponge) etc.

Gap Analysis

Gap analysis is an essential part of business management which is done by the management of an organization to compare its on-going progress with the intended performance. This process is performed in four steps of careful planning, collection of previous data, analysis of previous data and formation of a detailed report based on this collection which tells the organization that why it wasn’t able to achieve its desired goals.

New EU MDR and Gap Analysis

EU has recently made some changes regarding its Medical Device Regulations. These regulations were supposed to be implemented from May 2020 but due to recent outbreak of COVID-19 pandemic, the process has been delayed till May 2021. These new regulations demand a well-performed gap analysis from the manufacturers.

Competent Consultants can help you in the Process

In order to upgrade your combination medical devices as per the new regulations, you will require assistance from competent consultant services and we, at TS Q & E have been providing their services in this field for over a decade. From helping in upgrading ISO standards of various organizations to performing gap analysis, documentation, ISO consultancy and working in similar fields of business management, we believe in providing our valuable customers with the experience they cannot forget. If you are looking forward to upgrade your medical device as per the new EU regulations, then we shall undoubtedly help you. Just feel free to contact us and request a free quote.

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