Responsible Person Services- UKRP | EUAR | PRRC | SUSHVIN Consultancy Services Limited

At Sushvin Consultancy Services, we specialize in providing comprehensive consultancy services for UK Responsible Person (UKRP), EU Authorised Representative (EUAR), and Person Responsible for Regulatory Compliance (PRRC). Our team of experts is dedicated to helping you bring your medical devices to market safely and efficiently.

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UK Responsible Person (UKRP)

Your Gateway to the UK Market

With the UK’s medical device regulations evolving, having a UK Responsible Person (UKRP) is essential for non-UK manufacturers. Our UKRP services ensure that your products comply with UK law, providing you with peace of mind as you enter this vital market.

Our UKRP Services Include:

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EU Authorised Representative (EUAR)

Expanding Your Reach in Europe

As a non-European manufacturer, appointing an EU Authorised Representative (EUAR) is crucial for accessing the EU market. We have collaborations with our partners in the EU who can provide your organisation with EUAR services to help you navigate the regulatory landscape and ensure compliance with EU directives.

Our EUAR Services Include:

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Person Responsible for Regulatory Compliance (PRRC)

Ensuring Your Products Meet Regulatory Standards

The role of a Person Responsible for Regulatory Compliance (PRRC) professional is critical in the medical device industry. Our PRRC services provide you with the expertise needed to navigate complex registration processes and maintain compliance throughout your product lifecycle.

Both the manufacturers and the Authorized Representative are required to have within their organisation, or at their disposal, at least one PRRC who possesses the proper expertise and qualification in the field of medical devices or in vitro medical devices, as applicable, in the European Union.

Small and Medium Enterprises (SMEs) with fewer than 50 employees and a turnover not exceeding €10 million who may not have an individual with the necessary expertise and qualifications to serve as a PRRC. For these SMEs, Sushvin Consultants can step in as the PRRC, assisting in establishing regulatory compliance on their behalf.

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Our PRRC Services Include:

Registration Strategy Development: Tailor a registration strategy that aligns with your product and target market.
Compliance Audits: Conduct thorough audits to ensure adherence to regulatory standards.
Training and Support: Offer training sessions to equip your team with the knowledge to maintain compliance.
Annual PRRC Support Service: Our Annual PRRC Support Service Includes:
- Regulatory Oversight: Continuous monitoring and interpretation of applicable regulations to keep your products compliant.
- Documentation Management: Assistance with maintaining up-to-date technical documentation and design dossiers.
- Risk Management: Guidance on implementing and maintaining effective risk management processes to ensure patient safety.
- Audit Preparedness: Preparation for regulatory audits and inspections, including training your team on best practices.
- Training & Workshops: Regular training sessions to keep your staff informed about the latest regulatory changes and compliance strategies.

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Why Choose Us?

Discover expert guidance on UKRP, EUAR, and PRRC roles, ensuring compliance and regulatory success in the EU and UK. Learn more today!

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Get Started Today!

Navigating the regulatory landscape can be challenging, but with Sushvin Consultancy Services, you don’t have to go it alone. Contact us today to learn more about our UKRP, EUAR, and PRRC services and how we can assist you in bringing your medical devices to market successfully.

By partnering with Sushvin Consultancy Services, you’re not just choosing a consultancy; you’re choosing a commitment to quality and safety in medical device development. Let’s work together to bring your innovations to life!