Compliance and Regulatory Audit Services

Legal and regulatory compliance consulting for medical device registration, approval pathways, and post-market surveillance requirements across different regulatory jurisdictions.

Quality assurance and regulatory compliance support for medical device manufacturers. Ensures products meet MDR 2017/745 and EN ISO 13485:2016 standards.

Factory audit services for medical device manufacturers, providing compliance verification, quality system assessment, and regulatory documentation review. Supports manufacturers in meeting international standards and certification requirements for medical device production facilities.

Professional consulting services for medical device regulatory compliance and business strategy. Supports manufacturers in meeting international standards and regulatory requirements.

Expert consulting services providing analysis, reports, and certifications for accessibility compliance of medical devices and healthcare IT systems.

Regulatory consulting services supporting medical device and IVD manufacturers through CE marking, FDA 510(k) clearance, and UKCA certification processes. Provides technical documentation preparation, conformity assessment, risk management, and audit support to ensure compliance with EU MDR, EU IVDR, and UK regulatory requirements.

EU regulatory compliance and market access services for medical device manufacturers, including authorized representative designation, MDR/IVDR registration, and CE marking documentation to facilitate entry into European markets.

Professional services for laboratory and facility certification including regulatory documentation and compliance support. Assists organizations in achieving and maintaining accreditation standards.

Regulatory affairs support for diagnostic product development and market approval. Assists with FDA clearance, CE marking, and international regulatory compliance.

Regulatory, clinical, and quality consulting services for medical devices, in vitro diagnostics, and software-as-a-medical-device (SaMD). Supports CE marking and FDA approval pathways, quality system implementation (ISO 15189, ISO 17025), and compliance with MDR 2017/745, IVDR 2017/746, and 21 CFR standards. Services include regulatory strategy design, requirement analysis, and market authorization across the product lifecycle.

Regulatory consulting and software solutions enabling medical device manufacturers to navigate compliance requirements and accelerate market entry. Supports device classification, documentation, and regulatory strategy across EU and international markets.

Regulatory and quality management consulting services for medical device and IVD manufacturers. Provides expertise in UK, EU, and US regulatory compliance, device registration, management systems, post-market surveillance, and in-country representation throughout the product lifecycle.