Introduction A Quality Management System (QMS) is a structured framework that records processes, protocols, and duties to attain quality goals and directives. It aids in arranging and guiding an organisation’s operations to...

Introduction For UK-based manufacturers, obtaining UK quality management certification IS essential to ensure compliance with regulatory standards and maintain a competitive edge in the market. In the tightly regulated medical device sector,...

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...