Outsource

Oursource with IVDeology

Fully or partially outsource your quality/regulatory requirements, utilising IVDeology’s expert team and robust QMS. From PRRC to UKRP and other global territories, along with CDMO/CRO solutions from our parent company, Abingdon Health.

Outsource your Quality and Regulatory Department

PRRC

If you are looking to place devices on the EU market, IVDeology can act as your Person Responsible for Regulatory Compliance (PRRC).

UKRP

As your UK Responsible Person (UKRP) service we ensure you remain fully compliant with UK regulations while minimising the burden on your internal resources.

QMS Hosting

Ideal for SME customers who don’t need a fully-fledged QMS, we offer personalised hosting within our own private, cost-effective and transferable Quality Management System.

CDMO Services

If commercialisation is the next step for your project, our parent company, Abingdon Health, offers diagnostic contract development and manufacturing (CDMO) services.

PRRC

Manufacturers placing their products within the EU now need to appoint a Person Responsible for Regulatory Compliance (PRRC). SMEs that do not have the internal qualified staff can outsource and appoint IVDeology as its PRRC. Our team has significant experience across design & development, change control, risk management and vigilance to ensure:

  • Conformity of the device is checked
  • Technical Documentation and Declaration of Conformity are available and up to date
  • Post-market surveillance is effectively performed
  • Performance evaluation studies are performed correctly

UKRP

Non-UK manufacturers wanting to place product(s) on the UK market now need to appoint a UK Responsible Person (UKRP). IVDeology can support with product registration, certification and market maintenance to keep certification and compliance with the UK regulations, including:

  • Acting as your official UKRP
  • Managing UKCA mark registration and documentation
  • Serving as the point of contact for the MHRA
  • Vigilance reporting and incident management
  • Verification of technical documentation
  • Maintaining copies of required documentation
  • Facilitating communication with UK authorities

QMS Hosting

Med-tech companies who need to maintain an effective Quality Management System can now benefit from IVDeology’s QMS Hosting services. Benefits of QMS Hosting include:

  • Your documentation is accessible and securely stored
  • System validation is maintained and available to auditors
  • Regular updates are implemented seamlessly
  • Disaster recovery plans are in place and tested
  • Scalable for wider team use as your organisation grows

CDMO Services

Our parent company, Abingdon Health, provides contract development and manufacturing (CDMO) services, partnering with you across the entire value chain, from ideation through commercial launch. Our CDMO Services include:

  • Contract Development
  • Scale Up & Technical Transfer
  • Contract Manufacturing
  • Packaging
  • Commercial Services

Find out more by downloading their Lateral Flow Contract Services offering by clicking here.

Get In Touch To Discuss Your Project

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Case Study: Supporting Device Registration and Compliance in the UK Market

Client Overview

Based in the USA, this customer successfully registered over 50 medical devices with the MHRA and has been acting as a UK Responsible Person since 2021.

Challenge

The client needed support ensuring compliance with the UK regulations but also guidance beyond registrations and implementing a longer term strategy. The company did not have the capacity or the time to have someone internally dedicated to the project, which is where IVDeology came in.

Solution

To ensure compliance with UK regulations, the company underwent initial technical reviews for its first set of products. Once these reviews were completed, both the company and its devices were officially registered on the MHRA database.

As the company sought to expand its presence in the UK, additional products were progressively added to their registration, helping to increase their market availability.

The company also benefited from our assistance in meeting reporting obligations:

– Managing incident reports on the MORE platform

– Post-Market Surveillance (PMS) reports to the manufacturer and regularly update them on changes to UK regulations.

Results

We have also been working closely with the manufacturer to track the status of the In Vitro Diagnostic Regulation (IVDR) transition, ensuring that their devices can continue to be marketed in the UK without disruption. IVDeology were able to offer them support beyond the URKP title, and be able to save the company’s internal resources and time by being able to focus on aspects of the business.

Case Study: Class 1 Medical Device Company Outsources PRRC Role to IVDeology for Quality and Regulatory Support

Company Overview

A Class 1 medical device company specialising in non-invasive healthcare products sought the expertise of IVDeology to address the growing complexities of regulatory compliance. The company the internal expertise to fully meet the stringent requirements of global regulatory standards.

Challenge

One of the critical challenges the client faced was the need to appoint a Person Responsible for Regulatory Compliance (PRRC), as mandated by the EU MDR for medical device manufacturers.

SME companies often do not have the capabilities in house for the requirements and look to outsourcing the PRRC.

Solution

The customer had a long standing relationship of us supporting with QMS implementation and regs support, and were able to easily engage with us to outsource us as their PRRC. The benefits to the customer included:

  • Compliance: Taking over the responsibility for ensuring regulatory compliance and maintaining oversight of regulatory activities
  • Additional support: IVDeology provided continuous regulatory affairs support, conducting internal audits, supporting product registration, and preparing for any inspections or audits from regulatory authorities. This allowed the client to focus on other aspects of their business while ensuring their regulatory obligations were met.
  • Time saving: Offering PRRC services alongside QARA support meant this was a time saver for the customer as well as offering a more holistic approach