QA Consulting
Consulting firm that provides quality, regulatory, and microbiology services for medical devices and diagnostics across the product lifecycle. Core services include quality management system development and training, U.S. FDA and EU MDR regulatory strategy and transition support, regulatory submission and technical documentation authoring, auditing and post-market surveillance, design control and risk management, and microbiological and sterilization validation support. The firm states ISO 13485-aligned consulting capabilities and offers outsourced QA/RA resourcing.
Industries
Nr. of Employees
small (1-50)
Products
Quality System Development
Development of quality management systems for medical device manufacturers to ensure compliance with regulatory standards.
Regulatory Affairs
Consulting on regulatory strategies and submissions to comply with U.S. FDA and EU MDR requirements for medical devices.
Microbiology Analysis
Microbiological consulting and analysis services to support medical device sterilization and contamination control.
Medical Device Design Verification and Validation
Services to verify and validate medical device designs to ensure they meet specified requirements and regulatory standards.
Medical Device Validation Services
Validation services for medical devices to confirm manufacturing processes and product performance meet regulatory criteria.
Post-Market Compliance Auditing
Auditing services to ensure ongoing compliance of medical devices with regulatory and quality system requirements after market release.
Quality System Development
Development of quality management systems for medical device manufacturers to ensure compliance with regulatory standards.
Regulatory Affairs
Consulting on regulatory strategies and submissions to comply with U.S. FDA and EU MDR requirements for medical devices.
Microbiology Analysis
Microbiological consulting and analysis services to support medical device sterilization and contamination control.
Medical Device Design Verification and Validation
Services to verify and validate medical device designs to ensure they meet specified requirements and regulatory standards.
Medical Device Validation Services
Validation services for medical devices to confirm manufacturing processes and product performance meet regulatory criteria.
Post-Market Compliance Auditing
Auditing services to ensure ongoing compliance of medical devices with regulatory and quality system requirements after market release.
Services
Advisory and outsourced consulting covering quality, regulatory, post-market, and microbiology needs throughout device development and commercialization.
Creation and implementation of QMS documentation, performance of baseline gap analyses (including EU MDR and ISO 13485 alignment), and remediation planning to operationalize quality systems.
Regulatory planning and document preparation to support interactions with regulatory authorities, device classification, conformity assessment, submission readiness, and EUDAMED/registration activities.
Biocompatibility testing coordination, biological safety evaluation report generation, and interpretation of test results to support regulatory dossiers.
Support for sterilization process selection and validation and cleaning/reprocessing validation to demonstrate sterility assurance and cleaning effectiveness.
Establishing PMS and PMCF procedures, incident reporting support, trend analysis, and assistance with corrective actions and FSCA processes.
Advisory and outsourced consulting covering quality, regulatory, post-market, and microbiology needs throughout device development and commercialization.
Creation and implementation of QMS documentation, performance of baseline gap analyses (including EU MDR and ISO 13485 alignment), and remediation planning to operationalize quality systems.
Regulatory planning and document preparation to support interactions with regulatory authorities, device classification, conformity assessment, submission readiness, and EUDAMED/registration activities.
Biocompatibility testing coordination, biological safety evaluation report generation, and interpretation of test results to support regulatory dossiers.
Support for sterilization process selection and validation and cleaning/reprocessing validation to demonstrate sterility assurance and cleaning effectiveness.
Establishing PMS and PMCF procedures, incident reporting support, trend analysis, and assistance with corrective actions and FSCA processes.
Expertise Areas
- Quality management system development and remediation
- U.S. FDA and EU MDR regulatory strategy and transition planning
- Technical documentation and clinical evaluation reporting
- Post-market surveillance, vigilance, and PMCF
Key Technologies
- ISO 13485 compliance and QMS frameworks
- EU MDR transition and EUDAMED/UDI processes
- Clinical evaluation methodologies and literature review protocols
- Biocompatibility assessment (ISO 10993 series)
News & Updates
Announcement of a new Senior Quality and Microbiology Consultant joining the company.
Article discussing the role of audits in monitoring QMS performance and ensuring compliance after QMS updates.
Overview of cybersecurity considerations and best practices for medical device compliance and risk management.
Discussion of sterility test failures in radiation dose audits and recommended remediation steps.
Announcement of a new Senior Quality and Microbiology Consultant joining the company.
Article discussing the role of audits in monitoring QMS performance and ensuring compliance after QMS updates.
Overview of cybersecurity considerations and best practices for medical device compliance and risk management.
Discussion of sterility test failures in radiation dose audits and recommended remediation steps.