Introduction With ISO 13485 auditing services in the EU, companies can validate their adherence to these rigorous standards, instilling confidence in stakeholders and enhancing market competitiveness. A medical device, whether an implant,...

Introduction Quality management systems (QMS) are the backbone of ensuring quality and compliance in the medical device industry. This post is related to best practices for continuous improvement in medical device Quality...

Introduction The CE marking is a mandatory conformity marking for products sold in the European Economic Area, demonstrating compliance with applicable EU directives and regulations. It ensures that medical devices meet essential...

Introduction For manufacturers of in vitro diagnostic (IVD) devices seeking to market their products in the European Union, ensuring MDR compliance is a critical requirement. The EU Medical Device Regulation (MDR) has...

The Significance of Thorough Documentation for MDR ComplianceIntroductionKey Elements of Technical Documentation for MDR ComplianceMDR Compliance: A Documentation-Driven ProcessThe Advantages of Comprehensive DocumentationConclusionReferences Introduction On 26 May 2017, the Medical Device Regulation...

Introduction In today's globalised marketplace, manufacturers seeking to enter the European Union (EU) market must navigate a complex regulatory landscape. One of the most crucial requirements is obtaining the esteemed CE Marking...

The Evolving Regulatory Landscape The (MDR) Medical Device Registration in Europe (Regulation (EU) 2017/745) came into full effect in May 2021, replacing the previous Medical Devices Directive (MDD). The MDR introduces stricter...

Understanding the Regulatory Landscape The EU regulatory landscape for medical devices is dynamic and Complexities of EU medical device consulting. Consultants must stay current with the latest regulations, including amendments and interpretations....