SaMD Regulatory Consultant: What Digital Health Companies Need to Know
Digital health companies often begin by developing an app, software platform or algorithm as a technology product. Medical device requirements may only enter the conversation later, when a customer requests regulatory evidence, an investor questions the product’s status, an NHS organisation asks for compliance information or the company prepares for market entry. By that point, […]
510(k)-Exempt Medical Devices: Rules, Requirements and Steps
For many medical device manufacturers, the possibility of marketing a device in the United States without submitting a premarket notification can appear to offer a faster and less burdensome route to commercialisation. However, the term “510(k)-exempt” is often misunderstood. Exemption from premarket notification does not mean exemption from FDA regulation, nor does it mean that […]
UK Medical Device Regulatory Reform 2026, What the Pre-Market SI Means for Manufacturers
The UK medical device regulatory landscape is entering a period of significant change. Through the introduction of the Pre-Market Statutory Instrument (SI), the Medicines and Healthcare products Regulatory Agency (MHRA) aims to modernise the regulatory framework, improve patient access to innovative technologies and strengthen the UK’s position as an attractive market for MedTech innovation. For […]
Article 117 Notified Body Opinion Process Explained for Drug Device Combination Products
For pharmaceutical and combination product manufacturers, Article 117 of the Medical Device Regulation introduced a significant regulatory requirement that continues to generate questions across the industry. Organisations developing medicinal products that incorporate a medical device constituent must now demonstrate that the device component complies with the relevant General Safety and Performance Requirements (GSPRs) of the […]
Verification and Validation for Medical Devices, A Practical Guide to V&V Testing
Verification and Validation, often referred to as V&V, are among the most important activities within medical device development. They provide objective evidence that a device is safe, performs as intended and meets regulatory requirements. Under ISO 13485, EU MDR and international best practice, manufacturers must demonstrate that their devices satisfy both technical specifications and user […]
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 […]