Your regulatory function, without the headcount.

A managed RA/QA engagement is not a retainer for ad hoc questions — it is a structured monthly service where a named consultant from our team takes on defined responsibilities within your regulatory and quality function. This includes attending your product team meetings, owning regulatory submission timelines, maintaining your QMS documentation, managing external audits, and being the regulatory point of contact for your notified body or CDSCO.

The service is most valuable for: startups with a first device approaching CE or CDSCO submission who cannot justify a full-time hire yet; companies who have lost their RA/QA lead and need continuity while recruiting; and manufacturers who need senior oversight of a junior in-house team. We can also hold formal roles such as EU Person Responsible for Regulatory Compliance (PRRC) under EU MDR Article 15 or Authorised Representative.

Scope is agreed monthly and adjusted as the programme progresses. Early in a submission programme, effort is typically higher; once submissions are filed and the QMS is stable, the monthly commitment can reduce while maintaining accountability and continuity.

EU MDR Article 15 requires that every manufacturer (and, under certain conditions, authorised representatives and importers) designate at least one Person Responsible for Regulatory Compliance (PRRC). The PRRC must have verifiable qualifications: a degree in law, medicine, pharmacy, engineering, or a natural science, plus a minimum of one year's professional experience in regulatory affairs or quality management for medical devices. Alternatively, four years of professional experience in regulatory affairs or QMS can substitute for the degree.

The PRRC is personally responsible for ensuring device conformity before release, that technical documentation and DoCs are established and maintained, that post-market obligations are fulfilled, that vigilance reporting is performed, and that the QMS is in place. We can hold the PRRC role for manufacturers who do not have a qualified individual in-house, providing the formal accountability EU MDR requires while your team develops internal expertise.

Acquisitions, licensing deals, and investment rounds in medical devices require regulatory due diligence — assessment of whether the target company's regulatory approvals are valid, whether submissions are properly maintained, and whether any undisclosed regulatory risk exists. We conduct regulatory due diligence for buyers and investors, reviewing CDSCO licences, CE certificates, FDA clearance letters, QMS certification, and open CAPAs or notified body findings.

We also support sellers in preparing a regulatory data room that is audit-ready for buyer due diligence, ensuring all approvals are current and well-documented before the transaction process begins.