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Are you seeking expert regulatory support to navigate the complex MedTech compliance landscape in the UK? Now is your chance to accelerate your regulatory compliance process with the MedTech Accelerator: Rapid Regulatory Support Fund, a programme designed to support small and medium-sized enterprises (SMEs) like yours. This government-backed initiative offers up to £30,000 in funding to help you access expert regulatory advice and ensure your medical devices, diagnostics, or software meet the stringent UK and EU requirements.

 

With Global Regulatory Services (GRS) by your side, you can leverage this funding to expedite your path to market success and regulatory compliance.

 

What Is the MedTech Accelerator: Rapid Regulatory Support Fund?

 

The MedTech Accelerator: Rapid Regulatory Support Fund is an initiative funded by the UK Government’s Office for Life Sciences and delivered by CPI. It provides crucial financial support to UK-based SMEs that rely on external expertise to commercialise new MedTech products or re-register existing ones in line with updated regulations, such as UKCA marking or EU MDR/IVDR.

 

This fund is perfect for companies needing assistance to overcome the financial and technical barriers to achieving regulatory compliance. If you're developing or currently selling medical devices, diagnostics, or software as a medical device (SaMD), you can apply for up to £30,000 to cover eligible regulatory support services.

 

Why You Should Apply

MedTech regulations are constantly evolving, creating challenges for SMEs trying to stay compliant, especially with the divergence between UK and EU regulatory systems. For many businesses, the expertise needed to meet these requirements is external, creating a significant financial burden.

 

This fund is your opportunity to access that expertise with minimal financial strain. But with only 300 applications being accepted and a £4.2 million fund to distribute, early application is essential. The competition closes on 31st October 2024, so the sooner you act, the better your chances of securing support.

 

Services Covered by the Fund – And Offered by Global Regulatory Services

GRS provides a range of regulatory support services that are covered under the MedTech Accelerator fund, ensuring you receive high-quality, expert advice to meet compliance deadlines. These services include:

1. Regulatory Strategy Development
   We will help you formulate a comprehensive strategy tailored to your product, ensuring it meets UKCA and CE marking requirements.
2. Guidance on MDR, IVDR, and FDA
   Stay ahead of the curve with up-to-date advice on the EU Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR). We also provide guidance for companies entering the US market under the FDA’s regulations.
3. Technical File and Quality Management Systems (QMS)
   GRS will support you in developing robust technical documentation and implementing a Quality Management System (QMS) compliant with ISO 13485.
4. Mock Audits and Compliance Reviews
   Preparing for an audit? We conduct mock audits and provide comprehensive compliance reviews to ensure you’re fully prepared.
5. Clinical Guidance and Global Registrations
   If you're working on clinical trials or global product registration, GRS can offer expert guidance on how these fit within regulatory frameworks, ensuring your clinical data aligns with regulatory expectations.
6. Remedial Action
   Whether it’s electrical safety testing, biocompatibility testing, or addressing notified body concerns, we’re here to guide you through any regulatory challenges.

How GRS Can Help You Apply for the Fund

At GRS, we are not only experts in regulatory affairs but also committed to making your journey as seamless as possible. If you qualify for the MedTech Accelerator Fund, we can guide you through the application process and help you identify the best ways to use the funding for your regulatory needs.

 

The application window is short, and spaces are limited to 300 applicants. We strongly recommend that you apply as soon as possible. When you work with GRS, we will help you:

• Define your regulatory needs in line with the fund’s scope
• Select and tailor the appropriate services for your business
• Manage the claim and reimbursement process as your nominated regulatory affairs support provider

 

Why Choose Global Regulatory Services (GRS)?

Global Regulatory Services has 19 years of experience helping MedTech companies achieve and maintain regulatory compliance in the UK, EU, and globally. Our expert consultants understand the intricacies of medical device regulations and are committed to supporting SMEs as they navigate this complex landscape. We offer tailored, responsive, and comprehensive support, ensuring that you are fully compliant with the latest requirements.

 

Ready to Streamline Your Regulatory Compliance?

Don’t miss out on the opportunity to accelerate your product’s compliance journey. The MedTech Accelerator: Rapid Regulatory Support Fund offers you a straightforward way to access the support you need. With GRS, you can be confident that your regulatory needs will be handled with precision and expertise.

 

To get started, contact us today and find out how we can help you apply for the fund and ace your regulatory compliance with minimal hassle. Send us an email at grs@globalregulatoryservices.com or submit a webform via - https://globalregulatoryservices.com/global-regulatory-services-contact-details