Post-market Services
Ensure regulatory compliance and business continuity with PRRC and DPO interim solutions tailored to your needs.
As an organisation in the medical field, either developing, marketing or using medical devices, you may need to employ quality, regulatory, security and privacy personnel. As in many sectors, skilled & trained personnel are hard to get by, and you may need a temporary solution to fulfil a position.
We have a team of seasoned & experienced staff that can support your organisation on a temporary basis. Our PRRC and DPO interim solutions can assist in fulfilling the official European roles such as Data Protection Officer (DPO) required per the General Data Protection Regulation GDPR (2016/679) and the Person Responsible for Regulatory Compliance (PRRC), as required by the Medical Device Regulation – MDR (2017/745) and the In-Vitro Diagnostics Regulation – IVDR (2017/746). We can provide PRRC and DPO interim solutions with fractional QA, RA and Information Security support roles during start-up stages.
If a position needs to be temporarily filled with a broad scope of support or on a full-time basis, we aim to provide support by a wider team, to avoid a single staff member being employed on a full-time basis at a single organisation. This supports business continuity and a broader provision of expertise.
Explore our blog posts on MDR, IVDR, and EU AI Act medical device compliance to stay ahead of regulatory changes.
ISO/IEC 27001 has been the reference standard for information security management systems since 2005, and its third edition, ISO/IEC 27001:2022, was published on 25 October 2022 (ISO/IEC 27001:2022 and Amendment 1:2024). The transition from
Manufacturers have been able to register in EUDAMED, the European database on medical devices, since December 2020 for the Actor module and since October 2021 for UDI and device data, but only on a voluntary basis. That changed on 28
Using the EUDAMED UDI/Devices module became mandatory on 28 May 2026. This follows the Commission Decision (EU) 2025/2371, which formally declared the first four modules functional. Published in the Official Journal back on 27 November 2025, that decision kicked off
We are pleased to welcome Eva Kurilova-Sahin to the MedQAIR team. Eva brings a background in medicine, clinical science, radiology, and oncology research, together with experience in AI-enabled medical technology. Over the past 10 years, her work has brought her
The regulatory landscape for medical devices is becoming more complex as artificial intelligence becomes part of diagnosis, monitoring, treatment, and clinical decision support. For manufacturers, understanding the EU AI Act medical devices requirements is now essential alongside the existing Medical
Artificial intelligence is evolving faster than the regulatory frameworks around it. But that gap is beginning to close, with a growing body of AI medical device standards now moving towards publication and wider regulatory recognition.
Find answers to common questions about our services, compliance processes, and how we can assist your business.
Interim support provides temporary access to qualified professionals who can fulfil regulatory, quality, privacy, security, or compliance responsibilities while organisations recruit permanent staff, manage periods of growth, or address resource shortages.
The PRRC is a role required under MDR (2017/745) and IVDR (2017/746). The PRRC is responsible for overseeing regulatory compliance activities, including technical documentation, conformity assessment procedures, post-market obligations, and regulatory reporting requirements.
Yes. MedQAIR can provide interim PRRC support to help organisations maintain compliance and business continuity while recruiting permanent personnel or addressing temporary resource gaps.
A Data Protection Officer supports organisations in meeting GDPR obligations related to personal data protection, privacy governance, risk management, training, and regulatory compliance. Certain organisations are legally required to appoint a DPO depending on their activities and processing operations.
Yes. MedQAIR can provide interim DPO support, helping organisations establish privacy governance processes, manage GDPR obligations, and maintain oversight of data protection activities during temporary staffing transitions.
Yes. Interim support can be provided on either a full-time or fractional basis depending on the organisation’s needs, workload, and regulatory obligations. This allows organisations to access expertise without requiring a full-time appointment.
Yes. Interim support can include quality management, regulatory affairs, information security, management representative responsibilities, and other compliance-related functions where temporary expertise is required.
Interim specialists help ensure that regulatory activities, quality processes, documentation reviews, audits, supplier oversight, post-market obligations, and compliance activities continue without interruption during staffing changes or periods of rapid growth.
Yes. Start-ups often require regulatory, quality, privacy, or security expertise before building a full internal team. Interim support provides access to experienced professionals while allowing organisations to scale resources according to their stage of development.
The deployment timeline depends on the required expertise, responsibilities, and scope of work. Interim support is often used when organisations need experienced resources more quickly than traditional recruitment processes allow.
Yes. Interim specialists can work alongside broader quality, regulatory, information security, privacy, or audit support activities to help organisations address both operational responsibilities and strategic compliance initiatives.
A team-based approach helps reduce dependency on a single individual and provides access to broader expertise across quality, regulatory, privacy, information security, and compliance domains. This can improve business continuity and resilience during periods of organisational change.
Yes. Interim specialists can assist with audit preparation, regulatory inspections, documentation reviews, compliance assessments, submission activities, and remediation programmes while maintaining day-to-day compliance responsibilities.