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