David Heffelfinger's Contact Details

David Heffelfinger's Company Details

AltaQ

Bethesda, Maryland, United States • 3 Employees
Research

AltaQ provides global regulatory, quality, compliance, and validation consulting services. We believe in developing efficient and cost-effective regulatory solutions by understanding clients'​ needs and applying industry best practices to achieve success in the in-vitro diagnostics, medical device and pharmaceutical industries.AltaQ provides services in the following areas:Regulatory Affaris: 510(k) submissions, PMA Submissions, IDE Submissions, FDA Pre-Submissions, CE Marking, International RegistrationsQuality Assurance and Compliance:Quality System Development, Regulatory Gap Analysis and Mock Audits, Software Compliance and Validations, GMP, GLP, and GCP audits, Supplier Audits, ISO 13485, Corrective Action Management, Warning Letter Management, MDR and Recall Management, 21 CFR Part 11 compliance, CAPAValidations:Validation Master Planning, Process Validation, Facility Qualification, Equipment Qualification, Test Method Validation, Filling and Packaging Equipment Qualification. Software Compliance:Software Development LifeCycle Management, Softwware Development Plan (SDP), Software Requirement Specifications (SRS), Software Development Document (SDD), Software Verification and Validation Plan (SVVP), Software Requirement Traceability Matrix (SRTM), Software Configuration Management and Change Control Procedures, Electronic Document Management Systems, and Electronic Quality Management Systems