Charles – Medium

Charles

Reddit Survey: Best QMS software in the MedDev industry

Choosing the right QMS software is critical to success in the MedDev industry. To gain insight into popular options, I reached the Reddit…

2 min readJun 13, 2023

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Reddit Survey: Best QMS software in the MedDev industry

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Charles

Best QMS software for MedDev in 2022 (June)

To be as successful as possible in running a company, we always strive for better tools, techniques, and technologies to achieve results…

2 min readJun 13, 2022

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Best QMS software for MedDev in 2022 (June)

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Charles

How suffocating is a paper-based system vs. eQMS?

The most common case regarding poorly followed procedures is a paper-based system. From tracking, monitoring, updating, accessing…

1 min readOct 6, 2021

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How suffocating is a paper-based system vs. eQMS?

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Charles

Must-Have Documents and Records (ISO 9001 & ISO 13485)

We all know how important documentation and records are for QMS. We need to have proof “on paper” of how, why, where,... something was…

1 min readSep 28, 2021

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Must-Have Documents and Records (ISO 9001 & ISO 13485)

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Charles

Document Management in QMS software

We all already know very well that QMS refers to: “if it is not documented, it did not happen”.

2 min readAug 20, 2021

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Document Management in QMS software

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Charles

Prepared for Offsite Audits?

Auditing today seems much simpler than before. Offsite audits were known even before the pandemic but became very popular during COVID 19.

1 min readJul 8, 2021

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Prepared for Offsite Audits?

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Charles

The manufacturer of the medical device does not comply with ISO 13485?

One of the common ambiguities of medical device startups is exactly this:

1 min readJul 5, 2021

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The manufacturer of the medical device does not comply with ISO 13485?

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Charles

Remote Audit

We are all aware of how important internal and external audit is.

1 min readJul 2, 2021

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Remote Audit

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Charles

Similarities between ISO 13485:2016 and FDA QSR

A quick reality check of ISO 13485:2016, reveals that it actually looks more, smells more, and sounds more, like FDA’s QSR. Yep! If you…

1 min readJun 28, 2021

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Similarities between ISO 13485:2016 and FDA QSR

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Charles

How important is auditing for the company?

How do employees see the “audit”?

1 min readJun 25, 2021

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How important is auditing for the company?

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Charles

Charles

5 years medical regulatory consultant, before I was food inspector. Writing become my passion. Member of qmsWrappers author team.

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