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I will do iso 13485 qms documentation and certification for medical devices
Sonya Jamar
About this gig
Struggling to get your ISO 13485 QMS documentation audit ready without spending months on it?
I help medical device companies, startups, and manufacturers build complete, compliant ISO 13485 quality management systems that actually pass certification audits without the back and forth guesswork.
What I cover:
- Quality Manual, SOPs, and work instructions
- Risk management documentation (ISO 14971)
- Design and development records
- CAPA, complaint handling, and corrective action procedures
- CE Marking, EU MDR, FDA QSR alignment
- Gap analysis and audit readiness review
- Technical file preparation
Whether you are starting from scratch or need to update existing documentation to meet regulatory requirements, I will deliver documents that are structured, clear, and ready for your notified body or certification body audit.
I have worked with Class I, Class IIa, and Class IIb medical device companies across multiple markets including EU, UK, and US.
Every document is tailored to your device and company not generic templates.
Message me before placing an order so I can review your situation and recommend the right package for you.
Get to know Sonya Jamar
Sonya Jamar
Simplifying ISO Standards for Sustainable Business Growth
- FromUnited Kingdom
- Member sinceMay 2026
Languages
English, German
Navigating ISO standards shouldn't feel like a barrier to your business growth.
I help entrepreneurs turn compliance headaches into streamlined, audit-ready systems that actually make sense. Whether you are tackling ISO 9001 for the first time or expanding into 14001 and 45001, 27001, 50001 I’m here to simplify the process. I don’t just hand over generic templates; I build practical QMS documentation and audit strategies tailored to how you actually work. My goal is to help you earn that accredited certificate while making your team more efficient. Let’s get you certified.
Other Regulatory Compliance Consulting Services I Offer
FAQ
What exactly is included in ISO 13485 QMS documentation?
It includes a Quality Manual, SOPs, work instructions, forms, and records covering areas like design control, CAPA, risk management, and complaint handling everything a certification body checks.
Will these documents actually pass a certification audit?
Yes. The documents are built to meet ISO 13485:2016 clause requirements directly. I also include an audit readiness checklist so you can verify compliance before your audit date.
Can you help with both EU MDR and FDA QSR compliance?
Yes. I can align your QMS documentation to EU MDR 2017/745, FDA 21 CFR Part 820 (QSR), and MDSAP requirements depending on your target markets.
My company already has some QMS documents. Can you update them?
Absolutely. Send me what you have and I will do a gap analysis, identify what is missing or non-compliant, and update or complete your documentation to meet ISO 13485:2016.
What information do you need from me to start?
Device description, intended use, device classification, target market(s), and your company size. A short intake form is shared after you message me
Do you cover ISO 14971 risk management documentation?
Yes. Risk management documentation per ISO 14971 is included in the Standard and Premium packages. This covers the risk management plan, risk analysis, evaluation, and the risk management report
Can you prepare the technical file for CE Marking?
Yes. My service includes technical file structure and documentation aligned with EU MDR Annex II and III requirements, ready for submission to a Notified Body.
What device classes do you work with?
Class I, Class IIa, Class IIb, and some Class III medical devices. IVD devices under IVDR are also covered. Message me with your device details and I will confirm before you order.
What if I need documents for ISO 9001 alongside ISO 13485?
ISO 9001 and ISO 13485 share many common clauses. I can develop an integrated QMS that satisfies both standards simultaneously, saving you time and avoiding duplicate documentation.
