Quality Assurance
Achieve, and retain, compliance with intelligent systems designed with sustainable maintenance.
QMS Remediation
Remediate non-conformances. Write and negotiate action plans. Achieve close-outs. Contact us to review our track record of quality system improvement and finding resolution.
EQMS Implementations
Audits. Complaints. CAPAs. Nonconformance. Document Management. Change Control. Equipment. Work Orders. Service. Suppliers. Training. All can, and should be, electronic. Learn more.
Internal Audits
Required by most quality standards, and recommended for just about everyone. Immune helps regulated manufacturers perform routine internal audits. Find issues before they find the bottom line.
Supplier Audits
Ascertain the performance of top performers. We help to audit suppliers to most quality and EH&S standards; in most countries; to several languages. Learn more.
Technical Writing
An art within a discipline. We write most quality system documentation: training, risk documents, clinical evaluations, procedures, reports, instructions, root cause investigations, validations.
CAPA Handling
Perform meaningful investigations, identify real causes, and implement changes and corrective actions that increase system conformance with an eye toward scalability.
Regulatory Affairs
Testing, data, reports, directives, checklists, and everything in-between to complete Submissions, obtain market clearance, and sell product.
EU MDR Transitions
Update and improve documentation and systems to meet the new European Union Medical Device Regulation (EU) 2017/745.
Audit Representation
Audits, including internal audits, are a core component of quality management and continuous improvement. Learn more.
Post Market Clinical Followup
Conduct surveys. Gather evidence. Get help with PMCF, a core component of Post Market Surveillance under EU MDR.
Periodic Safety Updates
Prove benefits outweigh risks. Perform and report on investigations. Compile, submit, and update PSURs.
Clinical Evaluation Report
Compile physical and technical device information, outline therapeutic abilities, evaluate data, assess performance.
Training
Immune offers in-person, remote, and pre-made training modules for most quality system components.