Works
20, Dec 2024
Development of Osteosynthesis plates using 3D printing technology
Field of medical and health sciences has been under a process of continuous evolution. Many...
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20, Dec 2024
Clinical Evaluation Report (CER) for Medical Devices
A CER is a report based on in-depth analysis of clinical data which contains information...
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25, Jan 2024
Post-Market Surveillance for Medical Devices
Ensure patient safety, regulatory compliance, and market confidence with expert PMS practitioners from TSQE. Medical...
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10, Jul 2021
Authorized Representatives for Swiss Medical Device Manufacturers
Challenges Regarding MRA Update and their Impact Switzerland and the EU have made a Mutual...
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06, Nov 2020
Single Registration Number (SRN) Registration Support in EUDAMED
The EUDAMED’s 1st module is becoming compulsory from December 2020. All medical devices’ manufacturers, authorized representatives, importers,...
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11, Jul 2020
Bio-compatibility Evaluation Plan for Medical Devices
What is Bio-compatibility Evaluation? Biocompatibility evaluation is a process of determining a device’s compatibility with...
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23, Jun 2020
MDR Gap Analysis for Combination Medical Product
Organizing and running a medical devices business is a challenging task as compared to just...
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23, Jun 2020
MDR GAP Analysis and Remediation of Class I Medical Devices
Manufacturing and selling of medical devices is one of the most crucial businesses in the...
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23, Jun 2020
MDR GAP Analysis and Remediation of 3D Printed Products
Millions of individuals around the world struggle with their health. Among those, many are admitted...
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23, Jun 2020
Quality Management System (QMS) Audit
Starting a business and managing are two completely different tasks. While starting a business may...
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18, Jun 2020
MDR GAP Analysis Support on Human Factor Engineering- HFE Process
Human Factor Engineering (HFE) is a field of science which revolves around obtaining of information...
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05, Jun 2016
Bone Scanning and Reconstruction – 3D Printing Validation
The Problem Validation of 3D Printing Process for Medical purpose.The customer wanted to validate the 3D...
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