* Home
              * About Us
              * Medical Device
                  + Regulatory Affairs
                      o Registration and Audit Consultancy Services
                          - Global Medical Device Registration Services
                          - MDSAP Audit Services
                          - Software as a Medical Device (SaMD) Consultancy Services
                          - Drug-Device Combination Product Consultancy Services
                      o Responsible Person
                          - UK Reponsible Person (UKRP)
                          - EU Authorised Representative (EUAR)
                          - Person Responsible for Regulatory Compliance (PRRC)
                  + Regulatory Intelligence & Strategy
                      o Regulatory Intelligence
                      o Regulatory Strategy & Commercialisation
              * Quality Assurance
                  + QMS Services
              * Product Development
                  + Device Design & Development Support
                  + Risk Management
              * Medical Device Evaluation Services
                  + Clinical Evaluation
                  + Clinical Study
                  + Biological Evaluation
                  + Biological Testing
              * Vigilance
                  + Post-market Surveillance
              * Medical Device Testing Services
                  + Stability Study Design & Testing
                  + Microbiological Testing
                  + Sterilisation Validation
                  + Transportation Validation
                  + Clean Room Validation
          * Pharmaceutical
              * Regulatory Services
          * Cosmetics
              * Cosmetic Products Registration Services
              * Cosmetic Products Notifications Services
              * Submit A Cosmetic Product Notification (SCPN) FAQs
          * Blogs
          * Resources
              * Knowledge Centre
                  + Guidance - MDCG Endorsed Documents & Other Guidance
              * News & Updates
              * News Letter
          * Contact Us
              * Contact Us
              * Careers

      Partner With The Leaders In
      Quality & Regulatory Services For
      Medical Devices & Pharmaceutical
      Industries.

      Book A Free Appoinment
          What We Do

          Global Compliance Services For Medical Devices & Pharmaceutical Industries

            Responsible Person Services For Medical Devices

            Ensure compliance & smooth market access with expert guidance. Our dedicated professionals help manufacturers navigate regulatory complexities for seamless entry into global markets.

            Medical Device Regulatory Services

            Expert support for global compliance—MHRA, CE (MDR/IVDR), USFDA, and beyond. From regulatory strategy to post-market surveillance, we guide you through every step.


            Quality Management Services For Medical Devices

            Ensure compliance and optimize performance with expert solutions. Maintain high standards across the device lifecycle with streamlined quality management.


            Software As A Medical Device (SaMD)

            Navigate SaMD regulations with expert guidance. Ensure compliance, streamline development, and accelerate market access with specialized consultancy.

            Post-Market Surveillance For Medical Devices

            Strengthen patient safety and compliance with advanced monitoring. Gain valuable insights into device performance and risks for proactive decision-making.

            Medical Devices Testing Services

            Ensure safety, efficacy, and compliance with expert testing solutions. Deliver reliable healthcare innovations through rigorous evaluation.

            Cosmetic Product Registration Services

            Ensure smooth compliance with EU & UK regulations. Our expert consultancy simplifies documentation, regulatory approvals, and market entry for your cosmetic products.

            About SUSHVIN

            From Concept To Compliance: Your Global Regulatory Partner.

          Sushvin is a trusted partner in navigating the complex regulations of the medical device industry. With over 14 years of experience, we specialize in In Vitro Diagnostics (IVD) & provide expertise in regulatory consulting. Our core mission is to empower medical device manufacturers to achieve & maintain compliance, ensuring patient safety & market access.

                A Commitment to Quality & Compliance

                Sushvin's quality & regulatory compliance expertise ensures adherence to UK, EU, & global standards, ensuring trust in our products & facilitating entry into global markets.

                Expertise Across Multiple Domains

                We specialize in Advanced Wound Care, Continence, Critical Care, and Dental Implants, covering the entire medical device industry.

                0

                Clients Across The Globe

                0

                Devices Regulated

                0

                Years Of Experience

          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:

                    Medical Device Regulation 2017/745

                    Learn more

                    Quality Assurance And Compliance

                    Learn more

                    Auditing Solutions

                    Learn more

                    Brexit Transition

                    Learn more

                    PRRC - Person Responsible For Regulatory Compliance

                    Learn more

                    UK Responsible Person

                    Learn more

                    Medical Device Registrations

                    Learn more

                    PMS - Post Market Surveillance / PMCF

                    Learn more

                    Clinical Evaluation Reports

                    Learn more

                    Software As A Medical Device

                    Learn more

                    Combination Drug Device Support

                    Learn more
          Previous Next

          Latest Updates & Blog Post

          Blog

          European Commission Proposal COM (2025)1023 – Transforming MedTech Regulation

          News Letter

          Medical Device Compliance Updates Newsletter November 2025

          News Letter

          Medical Device Compliance Updates Newsletter October 2025

          Blog

          Understanding Predetermined Change Control Plans (PCCP) for Medical Devices

          News Letter

          Medical Device Compliance Updates Newsletter September 2025

          News Letter

          Medical Device Compliance Updates Newsletter August 2025

          Blog

          Key Updates in MDR & IVDR: Transition from MIR 7.2.1 to 7.3.1 for Incident Reporting

          Blog

          UK Regulatory Update July 2025: Navigating MHRA’s Recognition & Reliance Framework

          News Letter

          Medical Device Compliance Updates Newsletter July 2025

          Blog

          Regulatory Strategy for Combination Products: Compliance, FDA vs. EU MDR, and Key Steps 2025 Guide

          Blog

          Navigating the UK Medical Device Registration Process: A 2025 Guide

          News Letter

          Medical Devices Industry Updates Newsletter June 2025

          Blog

          UK’s PMS Overhaul: Strengthening Post – Market Surveillance Across Great Britain

          News Letter

          Medical Devices Industry Updates Newsletter May 2025

        Subscribe To Our Newsletter

        For Latest Updates, Subscribe to our monthly newsletter today!

        Subscribe Now
          More Than Just a Service, a Partnership.

          Listen To Our Success Stories.

            I cannot recommend Sushvin consultancy highly enough. They offer an exemplary service and we have benefited immensely over the last three years. Reliable, accurate information and efficient processing of applications. We use them for all our regulatory work, both for stand alone projects and for long term contracts like acting as our UK Responsible Person with the MHRA. They are very responsive and always come back with solutions to problems. We hope to continue expanding our portfolio of products under their supervision and guidance.

            Dr. Mudasser -Wimpole Pharmacy

            Aditya and Sushvin have consistently provided outstanding, seamless service. Their professionalism and dedication have instilled a strong sense of confidence in me. I am assured that our regulatory obligations are being managed effectively across all stakeholders, ensuring compliance and smooth operations. Their support has been invaluable in maintaining our high standards.

            Adam Dring -General Manager Implantcast UK

            Selecting Sushvin Consultancy Services Ltd., as our UK Responsible Person was one of the right decisions we made. Their team is highly knowledgeable and always available to answer our queries. They handled the registration of our custom-made medical devices with the MHRA efficiently and kept us informed throughout the process. Their commitment to compliance is truly commendable. We are appreciative for their support and highly recommend their services.

            Ashutosh Sahu -Manager Quality Assurance

            Jemedic are very pleased with our collaboration with Sushvin over the past few years. They have consistently supported us in a professional and highly competent manner with both regulatory and quality-related matters within MDR and GMP. Throughout our partnership, we have felt fully confident in our interactions with Sushvin and we look forward to continuing our cooperation.

            Elin Jern Muzdalo -Jemedic AB

            Aditya is a good quality manager and we enjoyed working with him. He has great communication skills and is always hands-on on tasks and deliverables. He has an excellent positive approach and a can-do attitude which brings a lot of positivity to the work environment.

            Prasanna Rangadurai -Holberg EEG

            We've been working with Sushvin on various projects and found them to be extremely knowledgeable and helpful. Any questions or issues that arise are responded to promptly and we receive regular updates without having to ask.

            Alan Boother - Head of Quality & Regulatory Affairs, Planer Limited

            Aditya is a professional through & through. A real team player with a positive attitude; this allows him & his team to tackle any issue. I would highly recommend engaging Aditya & Sushvin Consultancy Services if you want highly committed & knowledgeable teams working with you.

            Christian Martin

            We approached Sushvin company in 2021. Due to the company's growth, we had upcoming audits and an increasing workload. Aditya quickly responded to our request, gathered all the details of the requirements and current workload within no time, took the leadership of the QA/QC, and introduced a more effective way of working. We passed the first audit with no issues since this time. As MD, the whole company has the best experience working with Sushvin. Everything is handled in the most professional and timely manner way. I can only visualise our QA/QC Team with Sushvin's assistance. I highly recommend the service. After many years of working with different QA/QC consultants so far, this is my best experience.

            Sylwia Krasa - Head of Procurement, GP Supplies Limited

          Because Your Success is Our Mission

          Our Esteemed Partners

          Request A Call Back!

          Please fill the form and we will contact you with more information and advantages, request a call back now!

          Reach out today to discover how Sushvin's team can assist you.

          Submit Now

      Select a Service

        Medical Device Regulatory Services
        Medical Device QMS Services
        Medical Device Product Development Services
        Medical Device Evaluation Services
        Vigilance Services
        Medical Device Testing Services
        Pharmaceutical Regulatory Services
        Cosmetic Products Registration Services
        Cosmetic Products Notification Services
        Other Services

          Get In Touch

            * ADDRESS: 210D Sundon Park Road, Luton, LU3 3AL

            * CALL NOW: +44 7867782018

            * EMAIL: info@sushvin.com

            * Follow Us

            * Click Here To WhatsApp Us

            * Member Of

          About

            * Home
            * About Us
            * Blogs
            * Contact Us
            * Careers

              Resources

            * Knowledge Centre
            * News & Updates
            * News Letter

          Our Services

                Medical Devices

              * Regulatory Services
              * Quality Assurance
              * Product Development
              * Medical Device Evaluation Services
              * Vigilance
              * Medical Device Testing Services

                Pharmaceutical

              * Regulatory Services

                Cosmetics

              * Cosmetic Products Registration Services
              * Cosmetic Products Notifications Services
              * Submit A Cosmetic Product Notification (SCPN) FAQs

          Copyright © 2024 | All Rights Reserved.

          * Developed By E Vision Systems