Quality Assurance Services Quality management systems implementation and certification for medical device companies. Our Quality Assurance Services Every QA Service listed below in the Client’s Product lifecycle is performed to agreed on Requirements & Scope, and to applicable Standards & Regulations. D&D: → RA: → Our Quality Management Systems Our Specialists can provide Expert, Advanced or Competent level Skill as required by the Client, in the following. Walt Medical Editions! ™ — our ready-made QMS SOP suite and D&D Templates. See Walt Medical Editions! → Walt Medical Editions! → Build a World-Class Quality System Client Prospects CLICK to get Started! OR CLICK to Learn more of our Industries! Sales Affiliates CLICK to Contact Us! · Quality Planning · Requirements & Specifications · Regulatory Strategy · Quality Plans · Risk Management Plan (ISO 14971) · Design Input Review · Acceptance Criteria · Requirements Traceability · Design Controls · Concept & Prototyping · Regulatory Assessment · Design History File Set-up · Design Reviews · Preliminary Hazard Analysis · Prototype Build Records · V&V & Process Validation · Verification & Validation · Conformity & Clinical Evidence · Protocol & Report Review / Approval · IQ / OQ / PQ · Test Method Validation · Calibration · Inspection & Sampling Plans · Risk Management File · Risk & Reliability Engineering · Safety & Performance Compliance · Risk Management Reports · FMECA / FTA Review · Statistical Process Control (SPC) · Supplier Quality & Production Controls · Manufacturing Transfer & Supply Chain · Submissions & Market Authorization · Supplier Vetting, Approval & Qualification · Approved Supplier List · Supplier Audits · Purchasing Controls · Incoming Inspection · Design Transfer · Device Master Record (DMR) / Device History Record (DHR) · Nonconforming Product · Post-Market & Records · Reporting & Design Controls · Post-Market Compliance · Document Control (ECO / DCO) · Corrective & Preventive Action (CAPA) · Complaint Handling · Post-Market Surveillance · Management Review · Technical File · QMS & SOP Authorship · Full QMS Build & Factory Set-up · SOPs for Medical Device, IVD, OTC Pharmaceutical & Cosmetic Companies · To ISO 13485:2016, ISO 14971 & MDSAP · Training · Corporate SOP Training · Training Records & Competence · Internal Audit · Certified Lead Auditor: ISO 13485, ISO 9001 & ISO 14971 · Audit Plans & Schedules · Internal & MDSAP Audits · External Audit & Certification · Registrar & Notified Body Audit Preparation · FDA & Competent Authority Inspections · Certification, Surveillance & Re-certification · Findings Closed Out