Friday, September 29, 2023


Biotechnology News Magazine

Kolabtree: Releases Technical File Checklist for Medical Device Manufacturers

Latest Posts

Airway Therapeutics Completes Dose Escalation in Phase 1b Trial of Zelpultide Alfa (AT-100) for Very Preterm Infants at Risk for Bronchopulmonary Dysplasia

Airway Therapeutics began recruiting patients on March 28, 2023, for daily treatment up to 7 days at the highest dose of zelpultide alfa (rhSP-D) following a Data Safety Monitoring Committee (DSMC) report of no safety concerns.

Roche introduces navify® Algorithm Suite, a digital library of medical algorithms that enhances clinical decision-making to optimise patient care

At the global HIMSS1 Conference, Roche showcases navify Algorithm Suite, a single platform offering clinicians access to medical algorithms generating insights to help improve care decisions.

PathO3Gen Solutions UVZone® Proven 99.9993% Effective Against Candida Auris: Shoes and Floors in Healthcare Facilities Should Be Addressed as Outbreak Continues

PathO3Gen Solutions’ multi-patented UVZone Shoe Sanitizing Stations, when placed in high-traffic and high-risk areas, enhance healthcare facility infection control measures, and may improve overall hospital biosafety.

Pharming announces the first commercial shipments of Joenja® (leniolisib) to patients in the U.S.

Under the terms of Pharming's 2019 exclusive license agreement with Novartis for leniolisib, the corresponding first commercial sale of Joenja® triggers a $10 million milestone payment by Pharming to Novartis.

Kolabtree (an expert network) has announced the release of a new free resource for medical device manufacturers: The essential technical file checklist. Developed by regulatory experts, the checklist is aimed at medical device companies who want to place a device in the EU market and need to comply with MDR guidelines. It’s available to download for free here.

What is a technical file?

A technical file is a compilation of all the technical information about a medical device. This includes everything from the design of the product to how it’s manufactured and everything in between. It’s important to have a technical file because it provides essential information to regulators and helps ensure that medical devices are safe and effective. The technical file contains all the necessary documentation to support the regulatory submission, including test data, results, and analysis. It’s also used during post-market surveillance to help assess any safety issues that may arise with the device.

A technical file is a vital part of the EU MDR compliance process. In order to meet the requirements of the new regulation, medical device manufacturers must provide extensive technical documentation. This includes design and manufacturing files, technical specifications, user manuals, clinical evaluation reports, and more. Failure to submit a technical file can result in regulatory penalties, so it’s essential to make sure that your technical file is complete and accurate.

In order to make it easier for medical device manufacturers to comply with the EU MDR, Kolabtree has released a one-page technical file checklist. The checklist covers all of the essential components of a technical file, and helps you make sure that your documentation is complete and accurate. Kolabtree’s global network of medical device consultants offer services like medical writing, FDA/MDR compliance, data analysis, and more.

Download the Technical File checklist for free here


Latest Posts

Learn More




Our Sister Publication

Medical Device News Magazine