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Controlled technical documentation and reference standards laid out for review.

Quality and regulatory affairs

Regulatory readiness is built throughout development, not assembled at the end.

Regulatory strategy, quality management systems, design controls and submissions for medical devices across India, the United States and Europe.

Compliance is a design input, not a final inspection.

Quality Assurance and Regulatory Affairs (QA/RA) decides how much of your programme can be reused at submission. Teams that treat it as paperwork at the end rebuild months of work to satisfy a reviewer.

We set the regulatory strategy before the architecture is fixed, then run design controls and risk management alongside engineering so the technical file assembles itself from work that was already necessary.

Capabilities

Six capabilities that carry a submission.

01

Regulatory strategy

Intended use, claims, classification and pathway defined for each target market before development commits to an architecture.

02

Quality management systems

An operating QMS built around how your team actually works, with procedures people can follow under delivery pressure.

03

Design controls and risk management

Requirements, traceability, design reviews and a risk file with controls linked to verification evidence.

04

Regulatory submissions

Technical documentation, submission dossiers, reviewer queries and the evidence to answer them.

05

Standards and testing strategy

The applicable standards identified early, with a test plan that sequences electrical safety, EMC, biocompatibility and usability sensibly.

06

Post-market compliance

Vigilance, complaint handling, post-market surveillance and periodic reporting once the device is on the market.

Process

Define, map, build, submit, maintain.

01

Define

Intended use, claims and classification agreed across engineering, clinical and commercial.

02

Map

Pathway, applicable standards and evidence requirements mapped for each target market.

03

Build

Design controls, risk management and the technical file built alongside development.

04

Submit

Dossier assembled, submitted and defended through the review cycle.

05

Maintain

Post-market surveillance, change assessment and periodic reporting.

Markets

Pathways we cover, globally.

CDSCO

India

Medical Device Rules classification, licensing and registration for the Indian market.

FDA 510(k)

United States

Predicate strategy, substantial equivalence and premarket notification.

CE / MDR

Europe

Conformity assessment, technical documentation and notified body engagement.

Global

Other markets

Pathways in other regulated markets, mapped to the same technical file and evidence base wherever your product is heading.

What you get

What sits in your technical file.

A regulatory strategy naming the pathway and the evidence it requires.

A design history file with full requirement traceability.

A risk management file compliant with the applicable standards.

A submission dossier assembled for the target market.

Next step

Need clarity on your regulatory pathway?

Tell us the claims you want to make and the markets you are targeting.