Right Solution, on time.

Quality systems,
engineered
for regulated
medical devices.

Begin client intake

We partner with device innovators to build audit ready QMS, navigate FDA and EU MDR submissions, and ship safer product faster.

QUALITY MANAGEMANT

ISO
13485:2016

US COMPLIANCE

21 CFR Part
820

EU COMPLIANCE

EU MDR
745/2017

RISK MANAGEMENT

IS0
14971:2019

MDSAP

AUDIT APPROACH

OUR CORE COMPETENCY

A full stack quality & regulatory partner.

A black cat sitting on a gray blanket while holding a shiny, colorful ball in its paws.

QMS Implementation

Build ISO 13485 and 21 CFR 820 compliant quality systems from the ground up lean, practical, and audit ready.

A black and white drawing of a baseball glove with a baseball inside it.

Risk Management

ISO 14971 aligned hazard analysis, FMEA facilitation, and benefit risk determination across the lifecycle.

Illustration of a bicycle with a front basket and rear rack, viewed from the side.

Regulatory Submissions

510(k), De Novo, PMA and CE technical files. Strategy, authoring, and agency correspondence end- to- end.

The image depicts a black silhouette of a horse, standing on sandy ground with a background of light-colored sky.

From pre-submission strategy to post-market surveillance, our senior consultants embed with your team to deliver compliance that accelerates — not delays — your roadmap.

Audit & Remediation

Internal audits, mock FDA inspections, gap assessments, and CAPA programs that actually close findings.

A black and white cartoon skyline featuring various city buildings, including skyscrapers and towers, with a crescent moon in the dark sky.

Design Controls

Create, update, and leverage Design History Files that hold up under regulatory scrutiny.

A person holding a camera in front of their face, wearing glasses and a dark shirt.

Training & Advisory

Fractional QA/RA leadership and team training from design engineers to board level strategy

OUR APPROACH

Rigor without the red tape.

Every engagement begins the same way: listen carefully, assess honestly, and commit to a plan that respects your runway. Our custom approach ensures compliance without system bloat, by taking into account the size and scope of your company.

01

Discovery

A confidential intake call to understand your device, market, and regulatory posture.

02

Gap Assessment

We map your current state against applicable standards and identify the critical path.

03

Engagement Plan

A fixed-scope proposal with milestones, deliverables, and a formal statement of work (SOW).

04

Execution

Embedded, hands-on work — procedures, submissions, audits — alongside your team.