Medical Device Design and Development Under ISO 13485 and EU MDR
A robust medical device design and development process sits at the heart of every successful medical device. Whether a company is developing a single use device, a complex implant or software as a medical device (SaMD), regulatory authorities expect manufacturers to demonstrate that development has been planned, controlled, documented and validated. Under ISO 13485 and […]
MHRA Clinical Investigations for Medical Devices, A Practical Guide for UK Manufacturers
MHRA Clinical investigations are a critical component of medical device development and regulatory approval. For many manufacturers, generating robust clinical evidence is necessary to demonstrate safety, performance and clinical benefit before a device can achieve UKCA marking or access other regulated markets. In Great Britain, the Medicines and Healthcare products Regulatory Agency (MHRA) oversees clinical […]
Do MedTech Startups Need ISO 13485 Before Funding?
What ISO 13485 Actually Is ISO 13485 is the international quality management system standard for medical devices. It defines how organisations design, develop, manufacture and maintain medical devices in a controlled and compliant way. The standard covers areas such as document control, design and development, supplier management, risk management, complaints handling, corrective actions and post […]
NHS DTAC Explained, What Digital Health and MedTech Companies Need to Know
For digital health companies entering the NHS market, meeting the NHS Digital Technology Assessment Criteria, commonly known as DTAC, has become a critical requirement. DTAC is not simply an administrative checklist. It is a structured framework designed to ensure that digital healthcare technologies are safe, secure, interoperable and appropriate for use within NHS and social […]
DCB0129 Explained, Clinical Risk Management for NHS Digital Health Technologies
As digital health technologies become more integrated into NHS care delivery, clinical risk management has become a core expectation rather than an optional exercise. One of the most important frameworks governing this area in the UK is DCB0129, the NHS clinical risk management standard for manufacturers of health IT systems. For software as a medical […]
ISO 27001 and ISO 13485 Alignment, How MedTech Companies Avoid Duplication
As medical devices become more connected and software driven, the intersection between quality management and information security has become increasingly important. ISO 13485 defines how medical devices are designed, developed and maintained to ensure safety and performance, while ISO 27001 defines how organisations protect information, systems and data. For MedTech companies, particularly those developing software […]