5 Compliance Metrics You Should Use for Effective Product Compliance Management
Don’t know what compliance metrics to use for keeping track of your product compliance activities? Read this article to find out.
What is a Compliance Report? Why Do You Need It?
Read this article to learn what a compliance report is, why your organisation needs such a report, and what kind of information it should include.
Top 5 Reasons Why Risk Management is Important
This article presents five reasons why risk management is important and information on how to ensure you make risk-free medical devices.
What is Risk Management, and How to Create a Risk Management Plan?
Learn what a medical device risk management plan is and how to create one.
Most Common Electromagnetic Compatibility Issues in Electrical Equipment
This blog post presents the most common electromagnetic compatibility issues found in electrical equipment.
A Beginner’s Guide to Product Safety Standards
This article answers questions, such as “What is a standard?”, “What are EN, ISO and IEC standards?” and “How to select the correct safety standards?”.
A Beginner’s Glossary to Compliance
The following glossary contains key compliance terms and definitions that any new compliance professional must know before diving into the complex regulatory framework for the first time.
FDA Approval Process for Medical Devices: Step-by-Step Guide
This article focuses on the FDA approval process for medical devices, providing a step-by-step guide to accessing the US market.
Market Surveillance Regulation (EU) 2019/1020: Does It Apply to You?
This article provides information on the new EU Market Surveillance Regulation 2019/1020, coming into force on July 16th, 2021.
Responsibilities and Mandate of an EU Authorised Representative
This article helps you understand what an EU authorised representative is and what their general responsibilities are.
