The Compliant Path

Understand the strategic implications of the new EU regulation on electronic instructions for use (eIFU) for medical devices. Explore the co

Explore May 2026 medical device regulatory updates from the UK, EU, USA, Australia, Malaysia, Team-NB and ISO, including MDR, IVDR, UDI, lab

Explore March 2026 medical device compliance updates from Sushvin, including TGA software-based medical device exclusions, ISO 20417:2026, a

Stay updated with Sushvin Consultancy's the latest medical device regulatory and compliance updates for February 2026, including FDA guidanc

Learn how FDA’s QMSR 2026 replaces QSR and aligns with ISO 13485. Understand key changes, inspection updates, compliance impact, and prepara

January 2026 medical device compliance updates covering FDA wellness & CDS guidance, EU EUDAMED and ISO standards, Australia TGA consent to

Compliant sterilisation validation services for medical devices supporting ISO standards, EU MDR, FDA, and Notified Body audits.

Key FDA, EU MDR, EUDAMED User Guide, SFDA, IMDRF, ISO & MDSAP medical device compliance updates for December 2025. Stay audit‑ready with Sus

Explore MDCG 2025-10 post-market surveillance recommendations for medical devices & IVDs. Includes PMS plans, risk analysis, QMS links, and

Learn about the European Commission’s transformative 2025 medical device regulation reform (COM (2025)1023), including streamlined MDR/IVDR

Sushvin Consultancy's Nov 2025 Medical Devices Compliance & Regulatory News explains EUDAMED roll-out, PMCF debates, and digital label trend

Learn what predetermined change control plans are in medical device development, their regulatory importance, and how to implement them effe

Discover key developments in medical device compliance with Sushvin Consultancy's August 2025 newsletter. Get crucial updates and insights t