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CAPABILITIES

Areas of Expertise

Quality Management Systems (QMS)

  • Nonconformance & CAPA

  • ​Document Control

  • Quality Planning

  • Management Review

  • Risk Management

  • Supplier Management

  • External Standard Review

  • Patient Device Tracking

  • QMSR compliance

Complaint Handling & Post Market Surveillance

  • Complaint Handling System implementation

  • Integration support following M&A

  • Global Regulatory Reporting (MDR, Vigilance, etc.)

  • EU MDR (2017/745) & ISO 13485:2016 compliance

  • PMS Reports, PSUR, PMCF, etc.

USA &
European Union Regulatory Strategy

  • Investigative Device Exemption (IDE) Strategy and maintenance

  • Original premarket application (PMA) authoring

  • PMA Supplement authoring and review (180-day, real-time review, and 30-day notices)

  • Special 510(k) authoring and representation

  • Strategy and advice for Q-submissions and SIR meetings with FDA

  • EU MDR (2017/745) Class I-III Technical Documentation submission preparation and representation

Audit Support

  • Audit finding resolution (483, Consent Decree, etc.)

  • Regulatory body correspondence

  • Corrective Action drafting & implementation

Process Improvement

  • Backlog resolution (Complaint, NC/CAPA, etc.)

  • Procedural review & edits

  • ​Training

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