Medical device quality consulting
Quality systems that support development and commercial operations.
Zaliance helps manufacturers establish, maintain, and improve quality systems addressing ISO 13485, FDA QMSR, and applicable market requirements.
Support extends from procedures and implementation to auditing, inspection responses, remediation, and the post-market activities needed to maintain the system.
QMS implementation & improvement
Assess existing processes and establish a practical implementation or improvement plan. Define responsibilities, procedures, records, and training around the organization’s activities.
Deliverables may include: gap assessments, quality plans, procedures, implementation support, and staff training.
Design, software & validation controls
Connect requirements, risk management, design outputs, verification, validation, and change control. Support equipment, process, software, and electronic quality management system validation.
Relevant frameworks include ISO 14971 for risk management, IEC 62304 for medical device software lifecycle processes, and IEC 62366-1 for usability engineering.
Deliverables may include: process documentation, traceability reviews, validation plans, and documentation remediation.
Audits & inspection support
Conduct internal and supplier audits, assess inspection readiness, and help teams prepare personnel and records for regulatory or certification review.
Support includes ISO 13485 and MDSAP readiness, FDA inspection preparation, and evaluation of supplier and contract-manufacturer controls.
Deliverables may include: audit plans and reports, readiness assessments, and corrective-action plans.
FDA findings & CAPA remediation
Develop responses to FDA Form 483 observations and Warning Letters. Investigate the underlying issues, establish corrective actions, and define evidence for implementation and effectiveness.
Deliverables may include: response packages, root-cause analyses, remediation plans, and effectiveness-check strategies.
Post-market quality & regulatory compliance
Strengthen the processes that turn field experience into appropriate investigation, reporting, corrective action, and product improvement.
Areas of support include complaint handling, Medical Device Reporting assessments, post-market surveillance, CAPA, management review, and product-change control.
Deliverables may include: procedures, case reviews, trend analyses, management-review materials, and remediation support.
Ongoing quality management & training
Provide continuing support for quality operations, staff development, supplier oversight, and system maintenance.
Deliverables may include: outsourced quality management support, training programs, periodic reviews, and implementation assistance.
Quality & compliance insights
Practical perspectives on auditing, CAPA, software development, and post-market responsibilities.
QMS & software
CAPA effectiveness: evidence that the problem stayed corrected
Implementing a correction is only part of the evidence. A useful CAPA effectiveness review connects the cause, the changed control and enough post-change observation to support closure.
QMS & software
Can your quality system reconstruct a SaMD release?
A quality system should make the evidence for a deployed SaMD version retrievable and understandable, across development tools and cloud operations.
QMS & software
The code is ready. Is the SaMD change ready for release?
A passing build does not settle every release question. Connect clinical impact, evidence and submission decisions before committing to a SaMD change.