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OUR SERVICES

Regulatory

 

Angie Purvis, LLC brings a wealth of experience and knowledge of the regulations for medical devices and in vitro diagnostics in the USA and globally. If your organization is struggling with the changes in the EU (MDR and IVDR), Angie Purvis, LLC can assist with the transition.

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Services:

  • Regulatory Strategy development tailored to your product and your market strategy.

  • Regulatory assessments,

  • Regulatory writing (full service),

  • Presubmissions,

  • Regulatory meeting support,

  • Product Classifications,

  • Premarket Notifications (510k),

  • De Novo Applications,

  • Investigational Device Exemptions (IDE),

  • Analyte Specific Reagents (ASR),

  • Product Development Protocols,

  • Due Diligence Activities,

  • Readiness for IVDD to IVDR transition,

  • Technical File build and audit,

  • Review of labeling and promotional material

Quality Management

 

Our specialty is building fit-for-purpose, compliant Quality Management Systems for small and rapidly growing companies that need someone to translate the QMS requirements into language that scientists, engineering, and management team members can understand and implement efficiently and effectively.

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Services:

  • Quality Management System development and implementation (includes SOP writing) tailored to your company and culture.

  • Gap analysis, ISO 13485:2016 transition,

  • IVDR transition,

  • Design Control implementation and training for scientists, engineers, and management,

  • Risk Management,

  • Software Management (Verification, Validation, Machine Learning, Artificial Intelligence)

  • QA/QC,

  • Quality audits (internal and vendor),

  • CAPA, Verification and Validation protocols,

  • Document/Record Control,

  • Change Management

Scientific/Technical and Medical Writing

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We enjoy scientific and medical writing and pride ourselves in the high quality products we deliver.

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Services:

  • Customized standard operating procedures (SOPs),

  • Customized company policies,

  • Protocol writing,

  • Target Product Profile (TPP),

  • Regulatory submissions (presubmissions, investigational device exemption [IDE], 510k, premarket approval [PMA], EU notified bodies),

  • Device History File,

  • Device Master File,

  • Design Dossier/Technical File,

  • Performance Evaluation Report (PER) writing and updating,

  • Literature Review,

  • Software documentation,

  • Instructions for Use (IFU),

  • Technology transfer,

  • Scientific Manuscripts for peer-reviewed publications,

  • Grant strategy, Grant reviewing, Grant writing

Clinical Diagnostic Lab (CAP/CLIA)

 

Angie Purvis, PhD serves as a CLIA Laboratory Director for moderate- and high-complexity laboratory-based diagnostic labs across the USA and through the New York State Department of Health. We have expertise in all phases of building new laboratories and adding new diagnostic tests to an existing menu. We have experience helping companies navigate going to market as a laboratory developed test (LDT) first and then transitioning to an FDA-regulated product in the future.

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Services:

  • Laboratory Director (high-complexity)

  • Lab space selection, space planning,

  • Quality System building and implementing, training,

  • Laboratory information management system (LIMS) selection, implementation, and validation,

  • Equipment and test validation,

  • Resource planning,

  • OSHA-compliant protocols,

  • EPA-compliant protocols,

  • Mock inspections & internal audits,

  • Individual quality control plan (IQCP),

  • Inventory Management,

  • Quality Control, Reporting, and more. 

Making Notes
Clinical Development

 

We offer clinical development services to fit your needs.

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Services:

  • Clinical study design,

  • Clinical protocol writing and review,

  • Site initiation visits and auditing,

  • Clinical study reports

Doctor Examining CT Scan
Other Business Services

 

We work with small companies that need early advising on technology acquisition/evaluation or assistance with technology transfer. We create and review strategic pitch decks for small companies.

We work with investors and commercial innovation offices who want scientific, regulatory, and/or Quality due diligence performed on a company or technology prior to investment or acquisition.

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Services:

  • Technology evaluation,

  • Technology transfer,

  • Pitch decks,

  • Due diligence,

  • Market assessment,

  • Blog writing.

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© 2019 by Angie Purvis, LLC.

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