Regulatory affairs & quality assurance consulting
Support for development, market access, and continued compliance.
Zaliance works with startups, established manufacturers, and technology partners developing and maintaining cardiovascular medical devices.
Engagements combine clear priorities with practical deliverables, whether the need is a submission, a validation strategy, a quality system improvement, or support with a regulatory finding.
01 / CONSULTING
FDA Strategy & Submissions
Define the regulatory approach, prepare the submission, and address review questions. Support includes 510(k) submissions, Pre-Submissions, technical documentation, and assessment of product changes.
02 / CONSULTING
Clinical & Performance Evidence
Connect product claims with an appropriate evaluation strategy. Support includes validation planning, protocol and report review, clinical evaluation, and assessment of evidence supporting new capabilities.
03 / CONSULTING
Quality Systems, Audits & Post-Market Compliance
Establish, maintain, and improve the processes that support development and commercial operations. Services include QMS implementation, auditing, inspection support, complaint handling, CAPA, and remediation.
04 / CONSULTING
EU MDR Documentation & Remediation
Develop and improve technical documentation, clinical evaluation, and post-market plans. Resolve gaps and inconsistencies and prepare responses to notified body questions.
Ways to work together
Defined projects: A specific submission, assessment, protocol, documentation package, or training program, with agreed scope and deliverables.
Remediation engagements: Prioritized work to address inspection findings, audit nonconformities, process weaknesses, or accumulated documentation gaps.
Ongoing support: Continuing regulatory and quality assistance, including outsourced quality management, product-change assessment, staff support, and post-market activities.
Regulatory intelligence
Perspectives on regulatory developments and their implications for cardiovascular manufacturers.
Regulatory intelligence
Reading a clearance summary without overreading the clearance
A clearance summary can inform an evidence budget or predicate shortlist. Its value depends on separating what the record establishes from what it leaves unanswered.
Regulatory intelligence
Singapore permits two change notifications; but the release sequence still matters
Two change-notification applications can create flexibility in Singapore. Their value depends on dependencies, affected listings and implementation conditions.
Regulatory intelligence
Australia’s UDI rollout makes stock status a market-access decision
Australia’s UDI rollout can treat batches of the same device differently. Manufacturing, labelling and supply history help determine the applicable obligations.