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SERVICES

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Regulatory Strategy and Market Access

  • Regulatory landscape analysis and strategy development

  • Regulatory authority engagement

  • Device classification

  • Market access requirements determination

  • Predicate and equivalent device appraisal

  • Assessment of clearances for cross-jurisdictional use

  • Appraisal of clinical studies and data

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Regulatory Submissions and Support

  • Compilation of technical files, 510(k) and equivalent market access submissions

  • Independent review of draft submissions

  • Advice and support on specific submission requirements

  • Pre-submission meetings support

  • post-submission support with Notified Bodies and/or FDA​, including 10 day calls and submission issue requests

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Auditing and Peer Review

  • Regulatory requirements gap analysis (including AI/ML requirements, cybersecurity & clinical data)

  • Expert peer review of regulatory and supporting documentation

  • Second-opinion on regulatory strategy or classification

  • Regulatory and quality auditing for due diligence ​

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Quality Assurance Support

  • Independent internal auditing

  • Quality standards gap analysis: ISO 13485, ISO 14971, IEC 62304, IEC 82304, IEC 62366 (and more)

  • QMS design and implementation

  • Process design

  • CAPA support

  • Risk Management Support

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Training and Advice

  • Advice on regulatory impact on high-level strategic and commercial direction

  • Ad-hoc advice and support on regulatory or quality issues and questions

  • C-level overview introductory training on RA and QA essentials

  • Training on the regulatory landscape, timing, cost and sequencing.

  • Bespoke support and practical training on QMS and quality standards implementation

© 2023 by Penbran. All rights reserved.

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