Quality Due Diligence & Integration
Pre-acquisition quality due diligence and post-merger QMS alignment, including combination products and multi-site harmonization.
Medical Device Quality & Regulatory
Amirit Oshri-Chai
Quality and regulatory leadership that makes your next audit a non-event.
Former quality leadership at
A failed inspection is expensive. Being ready is a decision.
Warning letters, delayed launches and remediation cost far more than getting the quality system right the first time. AmiritQ brings executive-level experience, built at the world’s largest medical device organizations, to prepare your team long before the auditor arrives.
About
Two decades in medical device quality
Quality & Regulatory Compliance Executive · ISO 13485 Lead Auditor · PRRC
Over two decades building, scaling and defending quality management systems for medical device, healthcare and technology organizations, including senior quality leadership at GE Healthcare, HP and Medtronic.
My work spans the full quality lifecycle: quality due diligence and post-merger integration, gap assessments and remediation, and inspection readiness across FDA, ISO 13485:2016, EU MDR and MDSAP. Expertise reaches Class I–III sterile medical devices, where the margin for error is smallest.
An engineer by training and a leader by experience. I translate complex regulatory requirements into practical, right-sized systems your team can actually sustain.
Credentials
ISO 13485:2016 Lead Auditor
CMQ/OE
PRRC (EU MDR)
RBA Certified
MBA
B.Sc. Biomedical Engineering
Expertise
Where I create the most value
Focused engagements that reduce regulatory risk and turn quality into a competitive advantage.
Inspection & Audit Readiness
Mock audits, external audit hosting and inspection preparation for FDA, ISO 13485, EU MDR and MDSAP. Nothing is a surprise.
Gap Assessments & Remediation
Structured QMS gap analysis with clear, prioritized remediation: CAPA, investigations and DHF/RMF record remediation.
QMS Integration & Transformation
Design and scale compliant, right-sized quality systems that support growth instead of slowing it down.
Approach
A clear path to continuous readiness
Assess
Understand your product class, footprint and current QMS maturity against the standards that apply to you.
Prepare
Close the gaps, remediate records and align processes, with priorities matched to real regulatory risk.
Audit
Lead or host internal, supplier and notified-body audits with a steady hand and a prepared team.
Sustain
Embed the metrics, reviews and habits that keep you inspection-ready every day, not just before an audit.
Track record
Experience that stands up to scrutiny
20+
Years of quality leadership
I–III
Device classes covered
4
Frameworks: FDA · ISO 13485 · MDR · MDSAP
3
Global leaders: GE Healthcare · HP · Medtronic
Certified
ISO 13485:2016 Lead Auditor
CMQ/OE
PRRC (EU MDR)
RBA
FAQ
Good questions to ask first
Do you work with both early-stage and established companies?
Yes, from standing up a first compliant QMS for a startup to scaling and defending Class III systems at established manufacturers. Engagements are sized to your stage.
Which regulations and standards do you cover?
FDA (QSR/QMSR), ISO 13485:2016, EU MDR and MDSAP, with supporting expertise in ISO 14971 risk management and CAPA.
Can you help right before an FDA inspection?
Absolutely. Mock audits and focused inspection-readiness are among the most common and highest-impact engagements.
Do you support M&A quality due diligence?
Yes, pre-deal quality due diligence and post-merger QMS integration, including combination products and multi-site alignment.
How do we get started?
A short discovery call to understand your product, timeline and current state, then a clear, scoped proposal.
Contact
Let’s make your next audit a non-event.
Tell me where you are and what’s coming up. I’ll reply personally.