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SGCA Partners supports global regulatory and certification requirements

Medical Devices

Medical Device MDR Consulting
and Cybersecurity Support

Support EU MDR device classification, technical documentation, clinical evaluation and post-market activities, alongside FDA/EU MDR cybersecurity requirements.

Industrial Machinery

Machinery Cybersecurity
EU MR Requirements Support

Support EU MR cyber risk assessment, protection of safety-related software and data, control-system verification and CE technical documentation.

Explosion-Proof

Explosion-Proof Product
Quality and Audit Preparation

Support ISO/IEC 80079-34 quality systems and QAN/QAR audit preparation under the applicable ATEX and IECEx procedures.

Nuclear Safety

Ensuring Nuclear Safety &
Supply Chain Integrity

Support safety and reliability in the nuclear industry through ISO 19443 quality management and supply chain controls.

Our Expertise

Specialized Industry Sectors

Ensuring absolute regulatory compliance in the most demanding environments.

Medical Devices: MDR & Cybersecurity

EU MDR consulting for technical documentation, clinical evaluation and post-market activities, plus FDA/EU MDR cybersecurity support.

Nuclear Quality Management

ISO 19443 quality management, supplier evaluation, traceability and prevention of counterfeit, fraudulent and suspect items (CFSI).

Machinery Cybersecurity (EU MR)

EU MR cyber risk assessment, protection of safety-related software and data, and CE technical documentation support.
Insights

Latest Regulatory Updates

Stay informed with the latest regulatory trends and expert analysis reports across key global industries.

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