Core Services
Consulting across every framework
From quality management systems to market authorization — the standards and regulations we take clients through, and who each one applies to.
ISO Certification
Quality management systems designed to meet international standards with precision and reliability.
ISO 9001
ISO 9001 — Quality Management Systems
The world's most widely adopted quality standard, built into a system that satisfies auditors and improves how your organization runs.
Applies to: Any organization, any sector, any size
Read moreISO 13485
ISO 13485 — Medical Devices QMS
The quality management standard notified bodies expect from medical device manufacturers, aligned with your MDR or FDA pathway.
Applies to: Medical device manufacturers and suppliers
Read moreISO/IEC 17025
ISO/IEC 17025 — Testing & Calibration Laboratories
Accreditation support for laboratories that need their testing and calibration results recognised internationally.
Applies to: Testing and calibration laboratories
Read moreISO 29001
ISO 29001 — Petroleum, Petrochemical & Natural Gas
Sector-specific quality management for organizations supplying the oil, gas and petrochemical supply chain.
Applies to: Oil, gas and petrochemical suppliers
Read moreISO/IEC 80079-34
ISO/IEC 80079-34 — QMS for Ex Product Manufacture
Quality system requirements for manufacturers of equipment intended for use in explosive atmospheres.
Applies to: Ex and hazardous-area equipment manufacturers
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CE Marking
Complete Medical Device Regulation compliance support from technical files to market authorization.
EU MDR
EU MDR Regulatory Compliance
Classification, technical documentation and conformity assessment under Regulation (EU) 2017/745, through to your notified body review.
Applies to: Medical device manufacturers entering the EU market
Read moreEU IVDR
EU IVDR Regulatory Compliance
Performance evaluation and technical documentation under Regulation (EU) 2017/746 for in-vitro diagnostic devices.
Applies to: In-vitro diagnostic manufacturers
Read moreEUDAMED
EUDAMED Registration
Actor, device and UDI registration in the European database on medical devices, handled end to end.
Applies to: Manufacturers, authorised representatives and importers
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FDA Compliance
Navigate FDA requirements with expert guidance through registration, listing, and documentation.
510(k)
510(k) Premarket Notification
Predicate selection, substantial equivalence argument and submission dossier for devices taking the 510(k) route.
Applies to: Class II device manufacturers entering the US market
Read morePMA
Premarket Approval (PMA)
The most rigorous FDA pathway — clinical evidence strategy and modular submission support for high-risk devices.
Applies to: Class III device manufacturers
Read moreDe Novo
De Novo Classification
Classification requests for novel low-to-moderate risk devices with no valid predicate.
Applies to: Manufacturers of novel devices without a predicate
Read moreQMSR
QMSR — Quality Management System Regulation
Transitioning your quality system to the FDA's ISO 13485-harmonised QMSR requirements.
Applies to: Device manufacturers marketing in the United States
Read moreFDA Registration
FDA Establishment Registration & Device Listing
Establishment registration, device listing and US Agent arrangements kept current year to year.
Applies to: Domestic and foreign device establishments
Read more