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Marion Lepmets
The Internet is full of articles about the implementation of ISO 13485. They talk about “Getting management support”, “Obtain The Documents And Study The Requirements”, “Develop An Implementation Plan”, “Evolution of a Quality Management System”, and other seemingly complex topics. Although comprehensive, most of these articles are self-serving, aimed at...
Matteo Gubellini
Introduction The first contact with the Medical Device regulatory world is a shock for most startups. These companies usually have excellent technical and clinical ideas on how to improve the patient’s life, but little knowledge of the legal burdens required to bring the medical device to the market. The technical...
Matteo Gubellini
What is an “Electronic Signature”? Electronic signature means a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual’s handwritten signature. (21 CFR 11.3) In other words, to Electronically Sign a document means to...
Marion Lepmets
The Role of Cybersecurity in Medical Device Safety The Global medical device market is a $800 billion business that is rapidly growing, especially in the area of software as a medical device (SaMD). The majority of the SaMD segment is made up of the digital health and digital therapeutics solutions,...
Marion Lepmets
A mid-sized company in the medical technology sector faced a growing challenge: meeting the stringent requirements of the Medical Device Regulation (MDR) and FDA 21 CFR. As the company expanded, the existing ways of managing risks and documentation – such as Excel spreadsheets and paper-based processes – became increasingly inefficient...
Marion Lepmets
Introduction This medical device compliance guide focuses on the key requirements and strategies for navigating the regulatory landscape. We will cover the role of major regulatory bodies like the FDA, the classification of devices, and the importance of quality management. We will also discuss the challenges of global compliance and...
