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$
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I will prepare iso 13485 documentation and help you achieve certification
Mary
Level 2
About this gig
Hi, I'm Mary.
I specialize in ISO 13485 Quality Management Systems for medical device manufacturers worldwide.
Whether you're starting from scratch or preparing for certification, I can help you develop a compliant Quality Management System tailored to your organization.
My services include:
ISO 13485 documentation
Quality Manual
SOPs and procedures
Risk management integration
Internal audit support
Gap assessment
Certification readiness
CAPA and complaint handling
Design control documentation
Supplier management
I have experience supporting manufacturers of surgical, dental, orthopedic, diagnostic, and medical devices in multiple countries.
If you're preparing for ISO 13485 certification or need professional documentation, feel free to contact me before placing your order.
I look forward to helping your company achieve compliance.
Get to know Mary
Mary
Cybersecurity Expert: Your Trusted Partner
Level 2
- FromUnited States
- Member sinceJul 2024
- Avg. response time1 hour
- Last delivery1 month
Languages
English
Cybersecurity Expert: Your Trusted Partner
Safeguard your organization with expert cybersecurity services. I offer:
Comprehensive Security Solutions:
ISO Standard Compliance (27001, 27701, 27017, 27018, 22301, 20000, 9001)
Framework Implementation (NIST CSF, SOC, HIPAA, GDPR, PCI-DSS, PA DSS, C-TPAT, CMMC, CMMI)
Risk Management and Assessment
Security Audits and Testing
Incident Response Planning
Security Policy Development
Employee Security Awareness
My Portfolio
Other Regulatory Compliance Consulting Services I Offer
FAQ
Can you help us obtain ISO 13485 certification?
Yes. I provide documentation, implementation guidance, gap assessments, internal audits, and certification readiness support.
Are the documents customized?
Yes. Every document is tailored to your organization, products, and processes.
Do you provide Quality Manual and SOPs?
Yes. I prepare complete Quality Management System documentation.
Can you support startups?
Absolutely. Many clients begin implementing ISO 13485 before manufacturing starts.
Do you provide Internal Audit support?
Yes
Do you support certification audits?
Yes. I help clients prepare for both Stage 1 and Stage 2 certification audits.
Which industries do you support?
Medical devices, surgical instruments, dental products, orthopedic devices, IVDs, OEMs, contract manufacturers, private-label manufacturers, and related healthcare products.
Can you work with our existing documentation?
Yes. I can review, improve, and update your current Quality Management System.
