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Articles

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Blog

TÜV NORD Scandinavia MNB Is Bankrupt

Updated 11 days ago 2 comments

Dr. Oliver Eidel

QMS Software

Top 7 AI Prompts To Automate Your QMS (MCP)

3 months ago

Dr. Oliver Eidel

Blog

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

4 months ago

Dr. Oliver Eidel

QMS Software

Matrix Requirements (Matrix One) Alternative: What Companies Choose

Updated 12 days ago

Dr. Oliver Eidel

Questions

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Trend reporting is a PMS input or output?

Anonymous

2 months 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

5 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

5 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

5 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 · over 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 · over 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 · 7 months ago

Notified body review

Scarlet

Anonymous · 9 months ago

Notified body review

SGS (Belgium)

Anonymous · 12 months ago

Notified body review

BSI

Anonymous · about 1 year ago

MDCG Guidance

All MDCG documents

MDCG 2026-5: UDI assignment between manufacturers and distributors

Only the manufacturer may assign UDIs — the MDCG's answer to distributors obtaining their own UDI-DI codes for rebranded devices.

UDI · Endorsed Jul 2026

MDCG 2026-4: Management of SSCP in EUDAMED after mandatory use

Who uploads the SSCP to EUDAMED after the May 2026 mandatory date — the task moves from notified bodies to manufacturers, with a deadline for devices placed on the market before mandatory use.

EUDAMED · Endorsed Jun 2026

MDCG 2026-3: 2026 EMDN version history

The version history of the EMDN for 2026 — the authoritative record of the nomenclature as it stands after the annual revision.

Other · Endorsed Apr 2026

MDCG 2026-2: 2025-2026 annual revision change log

The consolidated change log of the 2025–2026 EMDN annual revision: every code insertion, modified term, deletion and split, in one spreadsheet.

Other · Endorsed Apr 2026

QMS Software Reviews

All QMS reviews

QMS software review

TrackWise Digital

Not publicly disclosed Specialized eQMS Flexible requirements

Bottom line: TrackWise Digital is a cloud enterprise QMS for life-sciences organizations that need broad quality workflows across sites and partner...

Dr. Oliver Eidel

6 days ago

QMS software review

SoftComply

$2,900/year shown for eQMS; Atlassian fees extra Specialized eQMS Specialized requirements Free trial

Bottom line: SoftComply is best understood as a set of regulated-content and workflow apps that turn Atlassian Confluence and Jira into a medical-d...

Dr. Oliver Eidel

6 days ago

QMS software review

Redmine

Free No eQMS Specialized requirements Free trial Exportable

Bottom line: Redmine is a capable open-source issue and project tracker that can support medical-device requirements, defects, changes and action t...

Dr. Oliver Eidel

6 days ago

QMS software review

QT9 QMS

Not publicly disclosed Specialized eQMS Flexible requirements Free trial

Bottom line: QT9 QMS is a broad, specialized quality system with an unusual commercial proposition: all QMS modules, unlimited training and support...

Dr. Oliver Eidel

6 days ago