Summary The FDA 510(k) Process is essential for proving device safety and equivalence to existing products in the U.S. market. US FDA 510k Consultants guide the manufacturers through regulatory strategy, predicate identification,...

Introduction Premarket approval (PMA) is a procedure used by the U.S. Food and Drug Administration (FDA) to assess the efficacy and safety of Class III medical devices. These devices either carry an...

Introduction EU Medical devices encompass a wide range of products for diagnosis, prevention, treatment, investigation, anatomical alterations, contraception, and sterilisation. In the European Union, these devices are regulated by the Medical Devices...

Introduction Navigating the regulatory landscape of medical device registration in the European Union (EU) can be complex and daunting. EU Medical Device consulting offers essential guidance to ensure that medical devices being...

Introduction In the dynamic world of medical devices, adhering to stringent quality standards is paramount. Today we provide step by step guide to ISO 13485 certification in the UK services through this...

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,...