MDR GAP Analysis and Remediation of 3D Printed Products

Millions of individuals around the world struggle with their health. Among those, many are admitted in the hospitals where they need support of different devices, machines and instruments which are produced by different manufacturers worldwide with great care. But sometimes, mishandlings happen which lead to various incidents. Different regulatory bodies around the world make sure the implementation of some strict laws regarding manufacturing and distribution of these medical devices. European Union has also made many strict laws regarding manufacturing and distribution of medical devices around the Europe.

Recently, regulatory changes are going to be enforced and the old European Medical Device Directives will be changed to Medical Device Regulations. These regulations were supposed to be imposed from May 2020, but implementation has been postponed till next year, due to COVID-19 pandemic.

What is a 3D Printed Medical Product?

The new MDR is also applied over the production and distribution of 3D printed medical devices and products as well.

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As it is comprehended that human beings share many common characteristics when it comes to their bodies. But one should also know that each individual also possesses some distinct features in his or her body. Many people around the world go for re-construction surgeries, where surgeons try to fix their damaged body parts (e.g. bones or vertebrae). To deal with the complexities of each individual, 3D printing was introduced in which MRI or CT scans are used to develop a 3D printed image of Patient-specific Implants (PSIs). Plastic powder is used to create a layer-by-layer shape which resembles geometry of the subject part. The resultant shape helps surgeons and doctors in in-depth understanding of their patient’s injured part, and to provide an alternative part and hence treating their patient better.

Gap Analysis for 3D printed Medical devices

Gap analysis is one of the most important parts of requirements management in a business. For the case of 3D printed medical devices, it is important to go for a gap analysis to understand the new EU MDR requirements and how these apply to 3D medical devices, your company is producing.

Gap Analysis is usually performed in four steps of data collection for the current state, analysis of current data with the required state, identifying gaps between the current and required state, formation of a detailed report based on the collection of data, analysis between present and current situation, and the identified gaps. This report determines the future implementation project plan to achieve organization’s compliance with the new requirement; here in this case, we have your 3D medical device and the new EU MDR.

TS Q & E can help Companies with the New EU MDR and Gap Analysis

Compliance to the new EU MDR regulations requires companies to adopt the same methodology for their medical devices and to perform a Gap analysis, and based on the gap analysis, move for the implementation, in order to keep their product in the EU market for future. One will be required to hire professional consultants for the job and TS Q & E are the ones with extensive experience on this area.

TS Q & E employs engineers and experienced consultants who are having a vast experience in business consultancy and management; we have been providing our services to our valuable clients for over a decade. TS Q & E is providing our services all over the Europe. If you are looking forward to perform a GAP analysis as per new requirements, don’t hesitate to contact us on our website and get a free quote based on your requirements.

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