ISO 13485:2016. FDA-registered. Audit-ready.
Quality documentation, regulatory filings, and audit responses available on request. We support sponsor regulatory teams and procurement teams with complete documentation packages for evidence files. Standard turnaround: five business days.
What's on file, what's available on request, and who to ask.
Regulatory documentation packages are prepared and updated continuously, not on demand. When a sponsor or procurement team requests a package, we send what we already have within five business days — not a custom build per request.
Standard documents (always on file)
Certificate of Conformance. Per-batch CoC available on request, signed by quality and traceable to the batch manufacturing record. CoC packages include batch ID, calibration data, and inspector signature.
ISO 13485:2016 certificate. Current certificate available for inclusion in sponsor evidence files. Issued by a notified body; annual recertification audits conducted without lapse.
FDA establishment registration. Active medical device manufacturer registration; registration number provided in regulatory submissions. Annual registration renewal completed without lapse.
Material Safety Data Sheets. For products containing materials requiring MSDS disclosure. Maintained current to applicable regulations.
Calibration procedures. Documented procedures for every instrument family, NIST-traceable. Available with audit trail records on request.
Counterfeit reporting procedures. Published process for distributors and end customers to report suspected counterfeit equipment. Includes case-tracking and response protocol.
Available on request
Supplier qualification questionnaires (completed). Audit responses (recent and historical). Methodology white papers (ETDRS, Pelli-Robson, iReST). Validation evidence binders for specific endpoint claims. Pre-submission documentation packages for novel trial protocols.
Audit support
Pre-audit consultation: we walk you through what's available, what we can prepare, and what timeline. On-site or remote audits accepted. Annual external audit reports available on request to qualified parties under appropriate confidentiality terms (NDA execution standard).
How to request documentation
Email qa@precision-vision.com with your organization, the documents needed, and the deadline. Standard turnaround is five business days; rush requests handled case-by-case for active trial timelines.
For data subject privacy requests under GDPR or CCPA, contact privacy@precision-vision.com directly — these route to a different team with a 30-day SLA.
Counterfeit equipment reporting
If you suspect counterfeit PV equipment is being marketed or distributed, email info@precision-vision.com with model number, source, and any imagery. We investigate every report and publish a quarterly summary of findings to authorized distributors.