Quality system conforming to ISO 13485:2016, evidenced through CE certification. Audit-ready.
Quality documentation, regulatory filings, and audit responses available on request. We support sponsor regulatory teams and procurement teams with documentation packages for evidence files. Contact us for current turnaround.
What's on file, what's available on request, and who to ask.
Regulatory documentation packages are prepared and maintained on an ongoing basis. When a sponsor or procurement team requests a package, we send what is on file and confirm the turnaround when we acknowledge the request.
Standard documents (on file)
Certificates of Conformance. Available on request where applicable; contact us for current availability and turnaround.
ISO 13485:2016 quality system. Manufactured under a quality system conforming to ISO 13485:2016 requirements, evidenced through CE certification.
Quality management system. Precision Vision operates a documented quality management system and manufactures under controlled, documented processes.
Material Safety Data Sheets. For products containing materials requiring MSDS disclosure. Maintained current to applicable regulations.
Calibration records. Calibration documentation is available on request for applicable instrument families; contact us for current availability.
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. Audit reports available on request to qualified parties under appropriate confidentiality terms (NDA execution standard).
How to request documentation
Email info@precision-vision.com with Regulatory documentation request in the subject line, together with your organization, the documents needed, and the deadline. We confirm turnaround when we acknowledge the request; rush requests handled case-by-case for active trial timelines.
For data subject privacy requests under GDPR or CCPA, email info@precision-vision.com with Privacy request in the subject line so it reaches the right team. We respond within 30 days.
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.