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I will prepare technical documentation for medical device compliance
Brian Collins
About this gig
Get Audit Ready Technical Documentation for Your Medical Device Fast
An incomplete technical file is the top reason devices get rejected.
Missing risk data. Gaps in your QMS. Weak clinical evaluation. Any one stalls your MDR submission, delays CE marking, or fails your audit. Notified Bodies do not give second chances on sloppy paperwork.
Most founders piece documentation from templates that do not match their device class, or skip sections they do not understand. Reviewers catch this fast, and rework costs more time than doing it right the first time.
I build your technical file and ISO 13485 QMS documentation from the ground up, structured to pass review.
What you get:
- Gap analysis against ISO 13485 and MDR requirements
- Complete technical file and design dossier
- Risk management documentation under ISO 14971
- Clinical evaluation report support
- Audit ready, submission ready files
You get documentation that satisfies auditors, so your device moves toward market without delay.
Message me your device type now, let's get your documentation audit ready.
Get to know Brian Collins
Brian Collins
Regulatory Compliance Specialist, MHRA, UKCA, CPNP and SCPN Documentation Expert
- FromUnited States
- Member sinceApr 2026
- Avg. response time1 hour
Languages
English, French, German
Launching a medical device or cosmetic product in the UK and EU?
One compliance gap can mean instant MHRA rejection, a blocked cosmetic listing, or a shipment frozen at customs. I help manufacturers, importers, and startups get MHRA registered, UKCA compliant, and CPNP/SCPN notified accurately, without guesswork or delays.
You get correct classification, clean documentation, and submissions built to pass, so your product reaches buyers on schedule instead of stuck in review.
Message me with your product type and let's map out your compliance path today.
Other Regulatory Compliance Consulting Services I Offer
FAQ
Do you write my full technical file?
Yes, from device classification through final documentation.
Can you help with ISO 13485 certification?
I prepare your QMS documentation for certification, not the certification itself, an accredited body issues that.
Do you cover risk management too?
Yes, ISO 14971 risk documentation is included from Standard up.
What's a Clinical Evaluation Report?
Required MDR evidence showing your device is safe and performs as intended. I can build or review it.
How long does this take?
2-10 days depending on package and device complexity.
Do you guarantee approval?
I guarantee accurate, audit ready documentation. Approval decisions rest with the Notified Body or FDA.
What device classes do you handle?
Class I, IIa, IIb, and III under EU MDR and UK MDR.
What do you need from me to start?
Device specs, intended use, and any existing documentation.
Can you work with existing but incomplete files?
Yes, gap analysis identifies exactly what's missing.
Why message before ordering?
So, I can confirm device class and scope the right package for you.
