Medical Device Integration for Software: What Errors Really Cost You
In September 1999, NASA’s Mars Climate Orbiter missed its intended orbit and disintegrated due to atmospheric stresses. An investigation indicated that the Orbiter’s Device failure resulted from two pieces of software (one on earth and one on the orbiter) miscommunicating with different interface setups. One software was set to interpret data as imperial measurements (inches, […]
The Benefits of ISO 13485 Quality Management System for Medical Device Manufacturers
In the highly regulated world of medical device manufacturing, quality and compliance are not optional, they are essential. ISO 13485:2016 is the internationally recognised standard for quality management systems (QMS) tailored specifically for the medical device industry. It helps organisations demonstrate their ability to consistently design, develop, produce, and deliver medical devices that meet regulatory […]
MDR and IVDR Transition Extension – Is There Enough Notified Body Resource?
In May 2017, the EU Medical Device Regulation 2017/745 (MDR) and In Vitro Diagnostic Regulation 2017/746 (IVDR) entered into force to replace the existing legislation for the Medical Device Directive (MDD) 93/42/EEC, Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC and In vitro Diagnostic Directive (IVDD) 98/79/EC. The initial transitional period for the MDR was three years, with an […]
Artificial Intelligence and Medical Devices – What the Future Holds
Artificial intelligence (AI) has the potential to transform the field of medicine and improve healthcare outcomes for patients. There are several ways in which AI can be used in conjunction with medical devices resulting in potential benefits and improvements in patient care. Let’s explore this in further detail: However, with every new technology comes great […]
The Benefits of Conducting a Gap Analysis for Your Business
Gap analysis is a process that compares an organisation’s current state to its desired future state in order to identify any gaps or disparities that need to be addressed through remediation activities. It is a process of reviewing and evaluating an organisation’s medical device documentation in order to identify gaps or deficiencies when compared to […]
UK Responsible Person: What Are the Requirements?
Since the UK’s exit from the EU in January 2021, several changes have been implemented, which are required by manufacturers to market their medical device(s), including IVDs, custom-made devices and system or procedure packs on the UK market. One of those changes has been the requirement for non-UK manufacturers to appoint a UK Responsible Person […]