Skip to main content

Medical Device Regulatory & Engineering Blog

Matrix ReqMatrix ConnectMatrix eIFUMatrix QualityMatrix Validate

Safe Medical Devices Act Definition: Ensuring Safety and Compliance in Medical Technology

August 01, 20244 min read

The Safe Medical Devices Act (SMDA) is a significant piece of U.S. legislation that was enacted in 1990. It’s designed to ensure the safety of ...

Ultimate Guide to the Software Development Lifecycle: Best Practices for Tech Innovators

July 31, 202415 min read

The Software Development Life Cycle (SDLC) is a systematic approach to developing software applications. It is a big-picture breakdown of all steps involved in software ...

Decoding Labeling Requirements: Understanding 21 CFR Part 801 for Medical Devices

July 30, 202411 min read

The Code of Federal Regulations (CFR) is a comprehensive set of rules and regulations established by federal agencies in the United States. Title 21 of ...

Medical Device Reporting (MDR): Compliance Guide to 21 CFR Part 803

July 29, 20245 min read

21 CFR Part 803 is a regulation under the United States Food and Drug Administration (FDA) that outlines the Medical Device Reporting (MDR) requirements. This ...

What is a Class II (Class 2) Medical Device in the US

July 27, 202413 min read

These Medical Devices hold a unique position in the Medical Device and Healthcare industries, offering a blend of complexity and necessity that surpasses basic Medical ...

Essential Templates for AI Risk Management within your QMS

July 26, 20248 min read

Managing Medical Device software risks for AI effectively requires a structured approach. To standardize this process, we created a flexible AI Risk Management template. This ...

Mastering ISO 11607: Packaging Standards for Medical Devices

July 25, 20245 min read

If you're in the medical device industry, you're no stranger to the labyrinth of regulations and standards that govern every step of your product's lifecycle. ...

3 FDA Medical Device Classes Explained Simply

July 24, 20244 min read

Understanding the FDA's medical device classification system is crucial for any med-tech startup. Navigating the regulatory landscape can be challenging, but knowing the basics of ...

Understanding MedWatch: FDA's Essential Program for Safety Information and Adverse Event Reporting

July 23, 20244 min read

Staying informed and compliant with regulatory requirements is not just essential but pivotal for success within the Medical Device industry. One cornerstone of regulatory diligence ...