Ensure compliance & smooth market access with expert guidance. Our dedicated professionals help manufacturers navigate regulatory complexities for seamless entry into global markets.
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.
Ensure compliance and optimize performance with expert solutions. Maintain high standards across the device lifecycle with streamlined quality management.
Navigate SaMD regulations with expert guidance. Ensure compliance, streamline development, and accelerate market access with specialized consultancy.
Strengthen patient safety and compliance with advanced monitoring. Gain valuable insights into device performance and risks for proactive decision-making.
Ensure safety, efficacy, and compliance with expert testing solutions. Deliver reliable healthcare innovations through rigorous evaluation.
Ensure smooth compliance with EU & UK regulations. Our expert consultancy simplifies documentation, regulatory approvals, and market entry for your cosmetic products.
Sushvin Consultancy is a trusted global 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.
Sushvin's quality & regulatory compliance expertise ensures adherence to UK, EU, & global standards, ensuring trust in our products & facilitating entry into global markets.
We specialize in Advanced Wound Care, Continence, Critical Care, and Dental Implants, covering the entire medical device industry.
Clients Across The Globe
Devices Regulated
Years Of Experience
Sushvin provides a wide range of services designed to cater to the diverse needs of our clients. Our extensive service offerings include:
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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.
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.
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.
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.
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.
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.
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.
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.
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