ISO 13485 Implementation Guide for Startups in 2025
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 promoting specific services of the […]
Software as a Medical Device (SaMD) Startup Guide to Compliance for 2025
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 world of reasonable certainties clashes […]
18 e-Signature Apps in Confluence Cloud (Comparison for 2025)
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 execute of a series of […]
How a Compliance Solution on Atlassian Cloud Empowered a Leading MedTech Company
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 and error-prone. This not only […]
What are the FDA 21 CFR 11 Compliant Electronic Records?
Title 21 of the Code of Federal Regulations, Part 11, also known as 21 CFR 11, deals with the requirements for Electronic Records and Electronic Signatures to be considered “trustworthy” by the FDA. If you work in the MedTech or Pharma sector, you probably have heard about this regulation plenty of times. And if you […]
What is an FDA 21 CFR 11 Compliant Electronic Signature?
Title 21 of the Code of Federal Regulations, Part 11, also known as 21 CFR 11, deals with the requirements for Electronic Records and Electronic Signatures to be considered “trustworthy” by the FDA. If you work in the MedTech or Pharma sector, you probably have heard about this regulation plenty of times. And if you […]
Managing Documents in the 21st Century
INTRODUCTION Although paper records still have their place in the modern industry, most companies use one or more software applications to manage documentation. Choosing the appropriate electronic document management system (eDMS) for your company is a critical task. You will commit the company and employees to a specific software tools for years to come. The […]
Demystifying Software Tool Validation
Ever wondered why software tool validation is crucial in the medical device industry? With modern medical regulations putting more emphasis on the management of software tools, it’s become an important part of the puzzle. Companies use various applications in the lifecycle of a device, and they must ensure they work as expected, based on how […]
Don’t Leave Your Quality Team Behind!
Your Development team might find the instructions from Quality and Compliance team time-consuming – slowing down their delivery time, but the regulatory standards are put in place to ensure the safety, effectiveness and integrity of products from different industries. There are significant consequences for non-compliance ranging from loss of business and legal penalties to your products being […]
Turning Confluence Cloud into a Compliant Document Management System
SoftComply Document Manager is the newest Confluence Cloud app for managing documents with dedicated Workflows and e-Signatures. With this app you will turn your Confluence Cloud into a compliant document management system with: Book a Dedicated Live Demo call to check out the full functionality of the SoftComply Document Manager! Following is a simple 5-steps […]
