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Specialized Sectors

Advanced regulatory compliance solutions for extreme environments and cybersecurity.

Medical Device Cybersecurity (FDA & EU MDR)

"Robust security guidance for the digital healthcare era as demanded by global markets."

Overview

Recently, both the US FDA and the European EU MDR have mandated rigorous cybersecurity requirements to ensure patient safety. SGCA Partners provides integrated security solutions that span from the initial design phase to post-market surveillance.

Core Services

  • FDA Premarket Submission Expert preparation of cybersecurity-related technical documentation (PMA/510k) and security risk management.
  • EU MDR GSPR Compliance Security design reviews aligned with the General Safety and Performance Requirements (GSPR) of Annex I.
  • SBOM (Software Bill of Materials) Establishment of software component management systems and comprehensive vulnerability analysis.
  • IEC 81001-5-1 Support for establishing security lifecycle processes for medical device software.

Machinery Field Evaluation (North America)

"The express route to the North American market, delivering innovative time and cost savings."

Overview

As an alternative to full NRTL listing, Field Evaluation allows for the immediate inspection of product safety at the installation site for approval. This is the most efficient solution for large-scale equipment or specialized exports.

Core Services

  • AHJ Approval Support On-site evaluations to ensure compliance with the safety standards required by local Authorities Having Jurisdiction (AHJ) across North America.
  • NFPA 79 & UL 508A Compliance Electrical safety standard reviews for industrial machinery and control panels.
  • Pre-audit Technical Services Proactive identification of non-conformities before field testing to ensure first-time approval.

Explosion-Proof Quality Systems (ISO/IEC 80079-34)

"The heart of Ex certification: establishing flawless mass-production quality systems."

Overview

Explosion-proof (ATEX/IECEx) certification requires not only safe product design but also a rigorous audit of the manufacturer's quality system (QAN/QAR). SGCA Partners is an industry leader in establishing Ex-specific quality systems.

Core Services

  • ISO/IEC 80079-34 Consulting Development of specialized quality manuals and procedure documents for Ex product manufacturing.
  • QAN/QAR Audit Preparation Pre-audit rehearsals and gap closures for factory audits conducted by European and international Ex certification bodies.
  • Traceability & Supply Chain Management Establishment of supply chain systems to maintain technical consistency of Ex-critical components.

Advanced Cybersecurity Regulations (EU CRA & RED)

"Navigating rapidly changing digital regulations: turning business risks into opportunities."

Overview

The EU Cyber Resilience Act (CRA) and the security requirements of the Radio Equipment Directive (RED), mandatory from 2026, are essential for all digital products. We provide rapid interpretation and strategic roadmaps for these evolving regulations.

Core Services

  • EU CRA (Cyber Resilience Act) Diagnostics of mandatory security requirements and conformity assessment support for CE marking.
  • RED (Radio Equipment Directive) Security Compliance strategies for network protection and privacy requirements for wireless communication devices.
  • Vulnerability Management Support for establishing vulnerability reporting structures and secure update distribution processes.