Qualomics
Qualomics provides quality and regulatory assistance to medical device start-ups and small companies, focusing on implementing FDA or ISO quality systems, inspection preparation, transfer to manufacturing, and internal auditing. Their mission is to add value to organizations by ensuring that quality systems work effectively and integrate operations, quality, and regulatory compliance.
Industries
Nr. of Employees
small (1-50)
Qualomics
Carlsbad, California, United States, North America
Products
Risk-Based QMS Checklist (download)
Practical checklist for applying a risk-based approach across a quality management system.
2025 FDA Warning Letter Trends (download)
Mid-year report summarizing CDRH warning letters, full letters, and an executive-summary analysis of compliance findings and trends.
Off-the-shelf SOP and validation template packages
Prewritten standard operating procedures, validation protocols, and report templates that can be customized for specific operations.
Risk-Based QMS Checklist (download)
Practical checklist for applying a risk-based approach across a quality management system.
2025 FDA Warning Letter Trends (download)
Mid-year report summarizing CDRH warning letters, full letters, and an executive-summary analysis of compliance findings and trends.
Off-the-shelf SOP and validation template packages
Prewritten standard operating procedures, validation protocols, and report templates that can be customized for specific operations.
Services
End-to-end consulting to design, implement, and optimize QMS processes, including gap assessments, policy and procedure development, and hands-on QA operations.
Support to define validation scope, author Master Validation Plans, conduct IQ/OQ/PQ, execute validation activities, and produce validation reports and revalidation plans.
On-site and remote audits of internal systems, suppliers, CROs/GLP labs, and tissue establishments; includes audit planning, execution, reporting, and remediation support.
Preparation and electronic submission of medical device reports to FDA on behalf of manufacturers, including account holder authorization, submission tracking, and audit-ready records.
Access to SOP templates, validation packages, training courses, membership community, and short expert consultation sessions to support QMS knowledge and execution.
End-to-end consulting to design, implement, and optimize QMS processes, including gap assessments, policy and procedure development, and hands-on QA operations.
Support to define validation scope, author Master Validation Plans, conduct IQ/OQ/PQ, execute validation activities, and produce validation reports and revalidation plans.
On-site and remote audits of internal systems, suppliers, CROs/GLP labs, and tissue establishments; includes audit planning, execution, reporting, and remediation support.
Preparation and electronic submission of medical device reports to FDA on behalf of manufacturers, including account holder authorization, submission tracking, and audit-ready records.
Access to SOP templates, validation packages, training courses, membership community, and short expert consultation sessions to support QMS knowledge and execution.
Expertise Areas
- Quality management system development
- Regulatory compliance for medical devices (FDA QSR and ISO 13485)
- Process validation and equipment qualification
- Electronic medical device reporting (eMDR) and adverse event workflows
Key Technologies
- Electronic medical device reporting (eMDR) via ESG/NextGen
- ISO 13485 risk-based QMS
- FDA Quality System Regulation (21 CFR Part 820)
- Good Laboratory Practice (21 CFR Part 58)
News & Updates
Using the FDA’s Establishment Registration and Device Listing database to identify contract manufacturers.
Highlights recurring issues with Medical Device Reporting and complaint handling in 2025.
Applying risk-based thinking practically across audits, CAPAs, supplier management, and training.
FDA warning letters to Chinese labs for data integrity violations, emphasizing the company's responsibility for data accuracy.
Guidance on applying risk-based approach in ISO 13485 quality systems.
Using the FDA’s Establishment Registration and Device Listing database to identify contract manufacturers.
Highlights recurring issues with Medical Device Reporting and complaint handling in 2025.
Applying risk-based thinking practically across audits, CAPAs, supplier management, and training.
FDA warning letters to Chinese labs for data integrity violations, emphasizing the company's responsibility for data accuracy.
Guidance on applying risk-based approach in ISO 13485 quality systems.