ISO 13485 and EU MDR
Medical device quality management, technical documentation, and full regulatory support for EU market entry, including MDR extension letter solutions.
Learn more: ISO 13485 and EU MDRCertification that opens doors to global markets.
QCRA Global helps manufacturers and service companies in Sialkot and beyond earn ISO certifications, CE marking, and FDA compliance, from first audit to final certificate.
Your certification roadmap
- ISO 9001 QualityReady
- ISO 13485 MedicalIn audit
- EU MDR 2017/745In review
- ISO 14001 EnvironmentReady
- Standards and schemes
- 25+
- Market access support
- EU · UK · US
- Audit to certificate
- End to end
- Audit-ready records
- Cloud eQMS
Everything you need to certify with confidence
Pick one standard or combine several. We guide your team through each requirement in plain language.
ISO 9001
Build a culture of continuous improvement and consistent product quality.
Learn more: ISO 9001ISO 14001
Reduce environmental impact, cut waste, and comply with regulations.
Learn more: ISO 14001
ISO 45001
Protect your workforce and reduce workplace accidents.
Learn more: ISO 45001
FDA and cGMP
FDA registration, cGMP compliance, and inspection preparedness.
Learn more: FDA and cGMPAlso certified through us
- ISO 14001
- ISO 50001
- ISO 22000
- ISO 27001
- ISO 37001
- ISO 10001
- ISO 31000
- HALAL
- CE Marking
- WRAP
- SEDEX
- SA 8000
- HACCP
- BSCI
- UDI
- SRN
- UK CA
- MHRA
- EUDAMED
Your trusted EU Authorized Representative
Sell medical devices in Europe with a local partner who handles compliance for you.
- Act as your EU Authorized Representative
- Ensure compliance with MDR 2017/745 and IVDR 2017/746
- Manage post-market surveillance and vigilance
- Prepare your EU Declaration of Conformity
ISO 13485:2016 and MDR ready
- E-signatures
- Traceability
- Audit-ready
How certification works
A clear path with no surprises.
Consult
Tell us about your business and goals.
Prepare
We close gaps in documents and processes.
Audit
Pass your assessment with expert guidance.
Certify
Receive your certificate and ongoing support.