Latest Updates & Blog Post

FDA QMSR regulation, Quality Management System Regulation, ISO 13485 FDA alignment, QSR vs QMSR, Medical device compliance 2026, FDA inspection changes, Medical device quality system regulation
FDA QMSR 2026: Complete Guide to Quality Management System Regulation Changes
Read more
Sterilisation validation for medical devices, Medical Device Sterilisation Validation - Sushvin Consultancy
Medical Device Sterilization Methods, Standards and NB Audit Criteria
Read more
MDCG 2025-10 Post Market Surveillance for Medical Devices & IVDs - Sushvin Consultancy
European Navigating MDCG 2025 10: Enhancing Post Market Monitoring for Medical Devices and IVDs
Read more
EU MDR consulting services, EU IVDR regulatory support, MDR IVDR reform 2025, COM (2025)1023 guidance, Medical device regulatory advisory EU, MDR IVDR transition support, EUDAMED compliance support, MDR IVDR consulting for startups and SMEs, Support for PECP removal under IVDR, Expert regulatory support for EU medtech reforms
European Commission Proposal COM (2025)1023 – Transforming MedTech Regulation
Read more
Understanding Predetermined Change Control Plans (PCCP) for Medical Devices
Understanding Predetermined Change Control Plans (PCCP) for Medical Devices
Read more
Key Updates in MDR & IVDR: Transition from MIR 7.2.1 to 7.3.1 for Incident Reporting
Key Updates in MDR & IVDR: Transition from MIR 7.2.1 to 7.3.1 for Incident Reporting
Read more
UK Regulatory Update July 2025: Navigating MHRA’s Recognition & Reliance Framework
UK Regulatory Update July 2025: Navigating MHRA’s Recognition & Reliance Framework
Read more
Regulatory Strategy for Combination Products: Compliance, FDA vs. EU MDR, and Key Steps 2025 Guide
Regulatory Strategy for Combination Products: Compliance, FDA vs. EU MDR, and Key Steps 2025 Guide
Read more
Navigating the UK Medical Device Registration Process: A 2025 Guide
Navigating the UK Medical Device Registration Process: A 2025 Guide
Read more
UK’s New PMS Framework- Medical Device Surveillance Update by Sushvin Consultancy
UK’s PMS Overhaul: Strengthening Post – Market Surveillance Across Great Britain
Read more
Unlocking Global Markets with MDSAP: Canada, US, Brazil, Japan & Australia
Unlocking Global Markets with MDSAP: Canada, US, Brazil, Japan & Australia
Read more
UK Medical Devices Regulations 2025: Key Amendments & Impact
The Medical Devices (Amendment) (Great Britain) Regulations 2025: Ensuring Regulatory Continuity in the UK
Read more
Why Does the NBOp Process Matter for Medical Device Manufacturers?
Understanding the Notified Body Opinion (NBOp) Process Under MDR Article 117
Read more
How TEAM NB's Position Paper Simplifies IVDR Certification for Manufacturers?
How TEAM NB's Position Paper Simplifies IVDR Certification for Manufacturers?
Read more
IVDR Compliance for Class D IVDs: The Role of EU Designated Reference Labs
IVDR Compliance for Class D IVDs: The Role of EU Designated Reference Labs
Read more
CE Mark Extension in the UK: How Sushvin Consultancy Supports Medical Devices Regulatory Compliance Until 2030
CE Mark Extension in the UK: How Sushvin Consultancy Supports Medical Devices Regulatory Compliance Until 2030
Read more
Stay updated on Post-Market Surveillance (PMS) requirements for medical devices in Great Britain. Learn about reporting obligations, timelines, and MHRA guidance.
Post-Market Surveillance (PMS) Requirements for Medical Devices in Great Britain
Read more
Medical Device PMS Statutory Instrument Regulations: Reporting, Safety & Compliance
Medical Device PMS Statutory Instrument Regulations: Reporting, Safety & Compliance
Read more
how to comply with MHRA new rules, recent changes in MHRA regulations for PMS, impact of PMS statutory instrument on healthcare, understanding PMS statutory instrument
Navigating the New Post-Market Surveillance Landscape in Great Britain: Understanding The Upcoming Statutory Instrument
Read more
Contact Sushvin for Cosmetic Products Registration Services to streamline your brand's entry into international markets.
How to Handle Regulatory Compliance for Cosmetics in International Markets
Read more
Why Your Business Needs a UK Responsible Person For Medical Devices
Why Your Business Needs a UK Responsible Person For Medical Devices
Read more
Key Elements for a Compliant QMS in Medical Device Manufacturing - ISO 13485 & FDA Guide
Key Elements For a Compliant QMS in Medical Device Manufacturing - ISO 13485 & FDA Guide
Read more
What Services Do Medical Device Regulatory Consultancy Provide At Various Stages Of The Regulatory Process, Such As Licensing, Application, And Marketing Authorization?
How to Choose the Right Regulatory Support for Your Medical Devices?
Read more
How does regulatory compliance impact the implantable medical devices market?
How does regulatory compliance impact the implantable medical devices market?
Read more
MHRA Consultation on Fee Proposal for 2025
UK Updates- MHRA Consultation on Fee Proposal for 2025
Read more

Discover Our Range of Services

Sushvin provides a wide range of services designed to cater to the diverse needs of our clients. Our extensive service offerings include:

Subscribe To Our Newsletter

For Latest Updates, Subscribe to our monthly newsletter today!