Choosing the right route shapes testing, clinical burden, timelines, and labelling. Getting this right early prevents costly pivots. We map the optimal compliant path for MDR or IVDR and for FDA aligned with the business strategy, align the evidence plan, and build submissions that tell one coherent story across risk, usability, clinical, and quality.

→ MDR and IVDR

CE marking depends on conformity to the general safety and performance requirements, solid clinical or performance evidence, and a technical file that a reviewer can navigate. We support classification, GSPR mapping, Technical Documentation completion, integration of clinical or performance evaluation, usability and risk, labelling and UDI, notified body readiness, and post-market plans that hold up in review.

→ FDA

The pathway you select, whether 510k, De Novo, or PMA, sets the cost and time. Mismatched evidence invites delays. We assess the route, design test, and clinical strategies that match guidance, lead Q Sub interactions, build the submission, and prepare clear responses to reviewer questions so cycles are reduced and entry to the United States is faster and synchronised with other business milestones.

→ GDPR

Connected devices and software rely on privacy by design. Trust and market access depend on it, and regulators increasingly examine it. We map data flows, define lawful bases, complete data protection impact assessments, and connect consent, retention, and vendor controls with your quality and security practices. The result is privacy compliance that supports clinical claims and patient confidence.

→ HMS

Safe laboratories, pilots, and field work protect people and continuity. Regulators expect safety to be integrated with quality. We set up practical health and safety procedures for prototyping and testing, provide role-based training, and align practices with your quality system so safety is lived every day and not only documented.

→ Regulatory Assessment

Regulatory expectations evolve, and missed changes can render plans invalid during development. We monitor relevant guidance, standards, and regulatory trends, assess their impact on your product portfolio, and translate them into clear actions for design, testing, and submissions so strategy stays current without disrupting execution.

→ Gap Analysis

Gaps often surface late, during audits or reviewer questions. We assess existing documentation, evidence and processes against applicable requirements and reviewer expectations, then define and execute a focused remediation plan that closes gaps efficiently and defensibly.

 

Let us connect