Quality & Compliance
Regulatory Affairs, Safety & Compliance Engineering
Engineering that clears CE, FDA, PED, ASME and national approvals without rework.
Overview
What this capability means at OneFit Projects
We translate regulations into engineering requirements and evidence. Our compliance engineers prepare technical files, risk assessments and submissions, coordinate with notified bodies and authorities, and build quality systems that survive audits.
How we engage
- Scoped studies with fixed deliverables and price
- Turnkey packages delivered with our engineering, quality and digital teams
- Embedded specialists working in your tools and processes
- Retained support under a framework agreement
Service lines
8 ways we deliver regulatory & compliance
Medical device regulatory
ISO 13485 QMS, EU MDR/IVDR technical documentation, FDA 510(k) and De Novo support, CDSCO registration.
Machinery & product safety
CE marking under the Machinery Regulation, LVD, EMC and ATEX; UKCA and other regional marks.
Pressure equipment compliance
ASME code stamps, PED modules, IBR (India), CRN (Canada) and design registration support.
Process safety
HAZOP, HAZID, LOPA, SIL assessment, QRA, ALARP demonstration and safety case development.
Quality management systems
Design, implementation and internal audit of ISO 9001, ISO 13485, IATF 16949, AS9100 and ISO 17025 systems.
Environmental, health & safety
ISO 14001 and ISO 45001 systems, machinery safety audits, ergonomics and noise assessments.
Data integrity & Part 11
Gap assessments and remediation for electronic records, audit trails and computerised systems.
Standards intelligence
Monitoring, interpretation and impact assessment of changing codes and regulations for your product portfolio.
Tools, platforms and standards
What we work with
We work in the platforms our clients already use, and we document to the codes their regulators, auditors and customers expect.
- ISO 13485
- ISO 14971
- IEC 60601
- IEC 62304
- EU MDR
- FDA 21 CFR
- Machinery Regulation 2023/1230
- PED
- ATEX
- IEC 61511
Where we apply it
Industries served by this capability
Medical Devices
Design, validate and manufacture devices that regulators trust and clinicians rely on.
Industry pagePharmaceutical
GMP facilities, equipment and systems qualified for global regulatory inspection.
Industry pageChemicals & Process
Process, mechanical and safety engineering for plants that run hot, high and hazardous.
Industry pageOil & Gas
Integrity, inspection and engineering for upstream, midstream and downstream assets.
Industry pageAutomotive & EV
Production lines, test systems and analytics for the electrified vehicle era.
Industry pageElectronics & Semiconductor
Cleanroom facilities, precision automation and thermal engineering for electronics.
Industry pageBiotech & Life Sciences
Lab to commercial scale, engineered for biological processes.
Industry pageRepresentative engagements
Regulatory & Compliance in practice
Plant and machinery valuation and technical due diligence for an acquisition
Valued three manufacturing sites and quantified compliance and capex backlog to support the transaction.
Design-by-analysis re-rating of high-pressure reactors
Re-rated four hydrogenation reactors to a higher operating pressure using ASME VIII Div 2 design-by-analysis and fatigue assessment.
Related capabilities
More from our quality & compliance practice
Need regulatory & compliance on your next project?
Share the scope, constraints and timeline. A senior engineer will respond with a practical path forward, whichever discipline it touches.