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I will conduct a gap analysis on your technical files
EU Regulatory and Quality Affairs Specialist
I'm a biomedical engineer who has been working as a regulatory consultant for the past 10 years specialising in medical device and IVD regulatory and quality affairs in the EU and UK. I have previousl...
About this Gig
The EU Medical Device Regulation (2017/745) and IVD Regulation (2017/746) have made compliance far more complex, especially for manufacturers with limited resources. Many struggle to understand what changes are needed to existing documentation and systems.
I offer a clear, actionable Gap Assessment to pinpoint where your current setup falls short of MDR/IVDR requirements. You'll receive a detailed report that:
- Cites the specific regulation
- States the gap or issue
- Recommends how to resolve it
This is the smartest first step toward confident, strategic compliance.
Document type:
Documentation
•
Reports
Industry:
Medical & biotech
Language:
English
Delivery style preference
Please inform the freelancer of any preferences or concerns regarding the use of AI tools in the completion and/or delivery of your order.
FAQ
What exactly is a Gap Assessment?
A Gap Assessment compares your current documentation or systems against MDR/IVDR requirements to identify what's missing or non-compliant. The result is a report with findings and recommendations.
What do I need to provide to get started?
You’ll need to share relevant technical documentation (e.g. your existing tech file). I’ll let you know exactly what’s needed once we start.
Will you help me fix the issues after the assessment?
This gig focuses on identifying gaps and giving recommendations. If you need help implementing the changes, I offer that as a separate service. Feel free to ask!
Is this suitable for early-stage or startup companies?
Yes. I tailor the assessment to your company’s stage and resources. It’s a smart way to understand your obligations early on and build the right compliance strategy.
Do you also assess IVDR documentation?
Yes, I assess both MDR and IVDR compliance, depending on your product type. Just specify which regulation you need support with when ordering.
Reviews
1 reviews for this Gig
| (1) | ||
| (0) | ||
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Rating Breakdown
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- Quality of delivery
- Value of delivery
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Most relevant
B basaaij
Repeat Client
Netherlands
I had a very pleasant collaboration with Kenneth. I now have a clear, professional GAP assessment that will help us move forward with our project. The communication and feedback were excellent, and the project was delivered efficiently. I'm happy to work with Kenneth on future projects.
$100-$200
Price
4 days
Duration
Helpful?
Reviews
1 reviews for this Gig
| (1) | ||
| (0) | ||
| (0) | ||
| (0) | ||
| (0) |
Rating Breakdown
- Seller communication level
- Quality of delivery
- Value of delivery
Sort By
Most relevant
B basaaij
Repeat Client
Netherlands
I had a very pleasant collaboration with Kenneth. I now have a clear, professional GAP assessment that will help us move forward with our project. The communication and feedback were excellent, and the project was delivered efficiently. I'm happy to work with Kenneth on future projects.
$100-$200
Price
4 days
Duration
Helpful?
