Services

Navigate global regulatory pathways with clarity and confidence. We support medical device and IVD companies in achieving compliance and market access across the EU, US, and international markets.

What we deliver:

• CE marking and FDA submissions:

  • Preparation and coordination of CE marking submissions under EU MDR

  • FDA 510(k), De Novo, and pre‑submission support

  • Regulatory gap assessments to identify compliance risks early

• Regulatory affairs and PMS strategy to successfully enter EU, US and international markets.

• Guidance on selecting and engaging with the right Notified Body for your device and regulatory pathway

• Prepare regulatory submission packages for CE marking and clearance in the US.

Ensure inspection readiness and clinical compliance across global markets. We help teams prepare confidently for Notified Body audits, FDA inspections, and internal quality reviews — with precision, clarity, and speed.

What we deliver:

• Regulatory compliance strategy and documentation alignment:

  • End‑to‑end review of QMS documentation for EU MDR, IVDR, FDA 21 CFR 820/QMSR, and ISO 13485

  • Alignment of technical documentation, risk files, and clinical evidence with regulatory expectations

• Audit preparation and mock inspections:

  • Full mock audits simulating Notified Body and FDA inspection conditions

  • Identification of gaps, weaknesses, and high‑risk areas before the real inspection

• CAPA and risk management integration:

  • Strengthening CAPA processes to meet FDA and MDR expectations

  • Integration of risk management (ISO 14971) into QMS and audit‑critical workflows

• Inspection coaching and post‑audit action plans

  • Coaching for SMEs and leadership teams on how to respond during audits

  • Structured remediation plans to address audit findings and prevent recurrence

Empower your teams with targeted, practical training programs designed for medical device Quality and Regulatory professionals. We build capability, confidence, and compliance excellence across all levels of your organization.

What we deliver:

• Custom workshops on EU MDR, FDA 21 CFR 820, ISO 13485:

  • Tailored training sessions for teams at all maturity levels

  • Practical interpretation of regulatory requirements

  • Hands‑on exercises to strengthen QMS and documentation practices

• Audit and inspection readiness training

  • Preparation for Notified Body audits and FDA inspections

  • Real‑world scenarios, mock interviews, and response coaching

  • Training aligned with MDR, IVDR, and FDA QMSR expectations

• Leadership coaching for QARA professionals

• Onboarding programs for QARA professionals

e specialize in authoring, reviewing, and refining medical device technical documentation that meets the highest standards of regulatory compliance and usability. Whether you are preparing for audits, submissions, or internal alignment, we ensure your documentation is complete, coherent, and inspection‑ready.

What we deliver:

• Design and Development File (DDF) Structured records that trace your product’s development lifecycle, aligned with ISO 13485 and FDA expectations.

• Medical Device File (MDF) Comprehensive documentation packages that define your product’s specifications, manufacturing processes, and quality controls.

• Risk Management Files Expertly compiled risk documentation per ISO 14971, including hazard analysis, risk evaluation, and mitigation strategies.

• Validation Protocols & Reports Clear, audit-ready documentation for IQ/OQ/PQ, software validation, and process validation activities.

• Labeling & IFU Development Regulatory-compliant Instructions for Use (IFU), labels, and packaging content tailored to your device class and market.

• Technical Files & Regulatory Submissions EU MDR Technical Documentation, FDA 510(k) submissions, and global registration dossiers — built for clarity and completeness.