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Articles

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QMS Software

Top 7 AI Prompts To Automate Your QMS (MCP)

about 1 month ago

Dr. Oliver Eidel

Blog

DMEA 2026 Thoughts: DiGAs Dead, More Scribes, Fewer Startups

about 2 months ago

Dr. Oliver Eidel

QMS Software

Matrix Requirements Alternative: What Companies Choose

3 months ago

Dr. Oliver Eidel

QMS Software

Dot Compliance Alternative: Better Fits For Faster-Moving Teams

3 months ago

Dr. Oliver Eidel

Questions

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Trend reporting is a PMS input or output?

Anonymous

14 days ago

Annex III of MDR: • The PMS plan shall address the collection and utilization of available information, in particular: information from trend reporting; • The post-market surveillance plan shall cov

No answers yet

Is internally used diagnostic software considered a medical device under MDR?

Anonymous · 1 comment

3 months ago

Our company has developed three software components related to EEG and ECG biomarkers to support psychiatric treatment decisions: • A web interface for hospitals and clinics to upload and store patien

Accepted 2 answers

Yes, your software would be considered Software as a Medical Device (SaMD) under the MDR. Even if you are not placing the software itself on the marke

Is a US-based test dataset mandatory for FDA clearance of dental AI software?

Anonymous · 1 comment

3 months ago

At our company, we are developing dental AI software and are preparing for FDA clearance in the US. We understand that having data from US sources is beneficial, but is it always mandatory? Our produc

Accepted 4 answers

In my experience, the FDA never explicitly stated what was wrong with our non-US clinical data, but they strongly suggested we include at least one US

How to ensure user manual readability and usability during testing?

Anonymous

3 months ago

What are effective methods for ensuring that user manuals or Instructions for Use (IFUs) are readable and usable during testing? Are there recommended tools or formulas for assessing readability?

Accepted 10 answers

You should only consider hazards that are caused by software failure when assigning the software safety class under IEC 62304. Hazards caused solely b

Videos

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7:56

AI-Assisted Writing of Technical Documentation

Dr. Oliver Eidel

8.8 K views · over 3 years ago

13:00

Documenting Software of Unknown Provenance (SOUP) for IEC 62304

Dr. Oliver Eidel

2.7 K views · about 5 years ago

12:12

Writing a Software Development and Maintenance Plan for IEC 62304 (Medical Device Compliance)

Dr. Oliver Eidel

2.6 K views · about 5 years ago

11:39

Writing a Quality Manual For Medical Device Quality Management (ISO 13485)

Dr. Oliver Eidel

1.4 K views · almost 4 years ago

Notified Body Reviews

All notified bodies

Notified body review

Scarlet

Anonymous · 5 months ago

Notified body review

Scarlet

Anonymous · 7 months ago

Notified body review

SGS (Belgium)

Anonymous · 10 months ago

Notified body review

BSI

Anonymous · 12 months ago

QMS Software Reviews

All QMS reviews

QMS software review

$2,500 (estimated)

MasterControl

Specialized eQMS Flexible requirements

MasterControl describes itself as "Intelligent QMS + MES + CMMS built for Life Science". It's unclear what the hell MES and CMMS stand for, but at ...

Dr. Oliver Eidel

3 months ago

QMS software review

8000€ / year

iPassport

Flexible eQMS No requirements

iPassport is another eQMS software available on the market. Its focus seems to mainly center around the UK market. iPassport Pricing iPassport's pr...

Dr. Oliver Eidel

4 months ago

QMS software review

$1,200+

SimplerQMS

Specialized eQMS Flexible requirements

SimplerQMS is a rather new entrant to the weird market of QMS software as it only was founded in 2022 by two Danish dudes - Allan Murphy Bruun and ...

Dr. Oliver Eidel

12 months ago

QMS software review

899$

FormlyAI

Specialized eQMS Specialized requirements Free trial

Updated in June 2025 with Formly's revised pricing model. FormlyAI is an interesting eQMS software. Let me start by saying that the eQMS software s...

Dr. Oliver Eidel

about 1 year ago