Services
ISO certification and regulatory compliance services
A comprehensive range of ISO certification and regulatory compliance services for organizations worldwide, covering documentation, implementation, audits and regulatory approvals under one expert team.
ISO & management systems
15 standards, one proven methodology.
Quality & Sector
Core QMS and sector-specific quality frameworks.
Environment & Safety
Protect people, planet and operations.
Information & AI
Security and responsible AI governance.
Medical & Laboratory
Devices, clinical and testing laboratories.
Food & Manufacturing
Food safety and good manufacturing practice.
Regulatory affairs
Medical device regulatory services across six jurisdictions.
U.S. Food & Drug Administration
Classification, 510(k), QMSR and registration for the US market.
United States
EU Medical Device Regulation
MDD-to-MDR transition, technical files and CE marking for Europe.
European Union
Medical Device Single Audit Program
One regulatory audit accepted by five major markets.
US · Canada · Brazil · Australia · Japan
Therapeutic Goods Administration
Classification, conformity evidence and ARTG inclusion for Australia.
Australia
Person Responsible for Regulatory Compliance
A qualified, outsourced PRRC for MDR and IVDR Article 15.
European Union
UK Medical Device Registration
DORS registration, UKRP and UKCA guidance for Great Britain.
United Kingdom
Service scope · ISO
ISO service types
- AISO documentationComplete documentation sets for any standard, available as templates or fully customized.
- BDocumentation and implementationDocumentation together with hands-on implementation and staff training.
- CInternal audit & gap analysisDocumentation, implementation and a formal internal audit report.
- DCertification serviceThird-party audit and certificate from an independent, accredited body.
- EFull packageAll four services above as one end-to-end engagement.
Service scope · RA
Regulatory service types
- ARegulatory strategyClassification and pathway selection for each target market.
- BTechnical documentationTechnical files, risk management, clinical and labeling evidence.
- CCompliance auditsAssessment of your compliance status to identify regulatory risks before an authority inspection.
- DRisk assessment and managementRisk-based strategies that help prevent costly non-compliance.
- ERepresentationPRRC and UK Responsible Person services for EU and GB markets.
Industries
Industries we serve.
From logistics and construction to healthcare, manufacturing and technology, we tailor every management system to the specific requirements of your industry.