Pure Engineering...

Leader in providing value added services to Medical Device and Pharmaceutical companies  

  • AQE was founded to help patients improve their quality of of life 

  • I provide a range of services for medical devices and pharmaceuticals:

    • QMS Implementation-FDA and EU MDR 

    • QMS QSIT and Supplier audits, CAPA execution, Complaints handling 

    • Validation-CSV, CSA, CQV, GAMP5, SaS 

    • Product Development- Design Controls, Verification, Risk Management, Usability, Biocompatibility, Electrical

    • Generation of process frameworks for SIMD IEC62304, and SAMD IEC82304 using TIR45 for Agile and ISO14971

    • Validation of hardware and software SAMD, SIMD systems. 

    • QA Compliance  for product and non-product software and hardware

    • Gap Assessments-FDA and EU MDR, Action Plan generation and execution

    • FDA 510K, DeNovo submissions and EU Notified Body CE mark preparation and Technical File preparation, DoC

    • Remediations-483, Warning Letter, and Consent decree 

  • Non-Product Software   

    • Extensive experience on validation methodologies, processes and regulations, including FDA's Software Guidance, Part 11, EU Annex 11. Guidelines such as GAMP5 (Good Automated Manufacturing Practice), CSA (Computer System Assurance), SaS (Software as a Service), Equipment, ERP and IT software systems

      • Software System validation; Documention implementation (Validation Plan, Traceability Matrix, Product Specification, Functional Specification, Risk Assessment, System Design, IQ and OQ, PQ write up, execution, and Reports, Validation Summary Reports 

      • GxP and Part 11 Assessment, Software Classification/Level of Concern, Risk Assessment, Change Management activities using tools like TrakWise and Service Now. Familiar with ALM and JIRA

      • Expert in authoring, reviewing and mentoring Development Teams on write up of Validation documents, Standard Operating Procedures for Design Controls -planning, reviews, writing software requirements, documenting code for maintainability, ensuring GDP (Good Documentation Practices)

      • Experience in enforcing adherence to regulatory requirements and standards during Project Planning, Project execution and Project delivery  

  • Product Software, Medical Device Software (SAMD IEC82304), Embedded Software (SIMD IEC62304) ​
    • Subject Matter Expert on implementing SDLCs for Agile/TIR45 under IEC82304, IEC62304,ISO14971
    • Proficient in compliance reviews of Development, Verification Activities,Deliverables per IEC82304,62304  
    • Validation of SaMD and Embedded Medical Device Software 
    • ScrumMaster. Former Software Developer in military systems
  • Product Development-Hardware and Software
    • Design Controls-dFMEA, pFMEA, uFMEA, Risk Management, V&V, Design Transfer, DHF, DMR creation
  • Non-Clinical Testing coordination with certified labs:Electrical Testing (ISO60601) Biocompatibility (ISO10993) ,Cytotoxicity,Sensitivity,Disinfection  
  • Clinical -ICH Clinical Study: Protocls, PMS (Clinical Evaluation Report (CER), Post Market Surveillance (PMS)

 

  • Other Testing-Shelf Life, Packaging ​

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  • Summative Usability/Human Factors
    • Study Planning, Implementation and Execution. Usability Engineering File per IEC 62366
  • Regulatory Affairs
    • FDA PMA,510K,DeNovo. IDE (Investigational Device Exemption), Breakthrough Device   
    • EU MDR (2017/745) Technical File Preparation for Class 2a/Class 3 Notified Body audit leading to CE mark and ISO certificate
  • QMS (Quality Management Systems) Implementation and Execution
    • Quality Manual Implementation-ISO13485, 21CFR Part820, 11, 210, 211, CAPA, Complaints, MDR, ISO14971  
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