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We specialize in delivering expert services that support and strengthen the operations of certification bodies, notified bodies, inspection bodies, and training organizations across a broad range of industries. With a network of highly qualified professionals and deep sectoral expertise, we empower your organization to uphold the highest standards of quality, compliance, and competence.

Auditors for Certification &
Notified Bodies

We provide experienced third-party auditors who are fully qualified to perform audits in compliance with international standards such as ISO/IEC 17021, ISO/IEC 17065, and MDR/IVDR requirements. Our auditors operate with full independence and impartiality, helping you:

  • Conduct management system audits (ISO 9001, ISO 13485, ISO 14001, ISO 45001, etc.)
  • Perform technical file reviews and clinical evaluation audits
  • Meet the requirements of accreditation and regulatory authorities

All auditors are vetted, trained, and regularly calibrated to ensure consistent delivery and technical depth.

Specialist Trainers for Regulatory & Standard Training

Whether you're a certification body looking to build internal competency or a training provider expanding your curriculum, our trainers deliver engaging, up-to-date courses in:

  • Quality Management Systems (QMS)
  • Medical Device Regulation (MDR), In Vitro Diagnostics (IVDR)
  • EU and global regulatory requirements
  • Risk management (ISO 14971), validation, and post-market surveillance
  • Auditor competence and assessment techniques

We tailor training to your audience—internal staff, auditors, clients, or regulators—and offer delivery both online and in person.

Technical Experts for Product & System Evaluations

Our technical experts bring sector-specific knowledge to support conformity assessments and file reviews. We supply experts in areas such as:

  • Medical devices (implantable, active, software as a medical device)
  • In vitro diagnostics
  • Electromedical equipment
  • Industrial and consumer products
  • Laboratory and testing technologies

Experts support regulatory review teams with detailed analysis, opinions, and evidence-based technical evaluations in compliance with EU and international requirements.

Third-Party Inspectors for Independent Assessments

As an impartial service provider, we deliver independent inspection services aligned with ISO/IEC 17020 requirements. Our inspectors assist inspection bodies and regulators with:

  • Product inspections (factory audits, initial production checks, pre-shipment)
  • Site evaluations and supplier audits
  • Compliance checks and process verifications
  • Surveillance assessments

All inspection work is fully documented, traceable, and delivered with integrity, ensuring confidence for you and your stakeholders.

Global Reach. Local Expertise.

With a global network of professionals, multilingual capabilities, and regional understanding, we provide agile support to organizations operating internationally. Whether you’re building capacity, scaling operations, or managing regulatory transitions, HK TEAM is your trusted partner.

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