
REGULATORY
Leverage our experience and excellent working relationships with FDA and EU regulatory agencies for your total product lifecycle.
Regulatory authorizations
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Strategizing, planning, technical writing, submitting to and corresponding with regulatory agencies
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US, EU, Canada, and other global markets
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510(k), PMA, De Novo, CE Mark, HC License, and support for international registrations
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Q-Submissions, IDE Applications
Product types
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All regulatory classes (I, II (a/b), III, IV)
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All types of medical devices
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Device – drug/biologic combination products
Consulting in US CFR Title 21, EU MDR, Canada MDR, and other international regulations
Due diligence for mergers and acquisitions

DEVELOPMENT
We coach our clients through design and development planning, product requirements definition, preclinical and clinical protocol development and execution, risk assessments, labeling content, and all aspects of design controls to ensure the data package for submission is right the first time.
Product & Process Risk Management
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Hazard analyses
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FMEAs (Design, Use, Process)
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Risk management plans, reports, files
Product Development Support
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Design verification and validation planning
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Design control and technical documentation
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Liaison with biomaterial and pre-clinical test services and experts
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Literature reviews and clinical evaluation reports
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Clinical trial design

QUALITY
Whether setting up your first quality system or making improvements to meet new standards or address audit findings, we provide solutions that don’t overburden your operations.
Quality Systems & Compliance
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Consulting, gap analyses, audits, and implementation
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ISO 13485, MDSAP, and regulatory requirements for quality systems
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Risk-based decision making throughout the product lifecycle
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On-site support for FDA inspections and third-party audits
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Warning letter remediation

POST MARKET
We specialize in post‐market surveillance systems
that provide continuous feedback about your
marketed products and ensure compliance with
post‐market reporting obligations.
Post-Market Surveillance
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PMS and clinical evaluation plans
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PMCF study design
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Initial CER, CER updates, and PMS reports / PSURs
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Complaint handling, vigilance, and regulatory reporting
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Field action planning and implementation