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Articles by Jón Bergsteinsson
ISO 14155:2026 compliance checklist: sponsor and investigator responsibilities
ISO 14155:2026 is the international standard for Good Clinical Practice (GCP) in the clinical investigation of medical devices for human subjects. Published on March 23, 2026, it is the fourth edition of the standard and replaces ISO 14155:2020 with no transition period.
Clinical evidence for first-time study teams: what to get right before subject one
Most of the manufacturers I talk with are running their first clinical study with a team that has never run one before. A design engineer becomes the de facto study lead. A regulatory affairs hire from a different device class gets handed a protocol and a spreadsheet. Nobody on staff has managed site relationships, query resolution, or an audit trail before, and the study is already on the calendar.
Spreadsheets vs. EDC: the real cost of running a clinical study on paper and Excel
Every year, medical device teams make the same calculation. They know a purpose-built electronic data capture (EDC) system exists. They have seen the demos. They understand the concept. And then someone looks at the budget and says: "We can manage this in Excel for now." It is a reasonable-sounding decision. Excel is already licensed. The team knows how to use it. Paper case report forms (CRFs) have been a clinical staple for decades.
Welcome Enzyme to the Greenlight Guru Family
At Greenlight Guru, our mission has always been to empower MedTech and life sciences innovators with the tools they need to bring safe, effective, and life-changing products to market—faster and with more confidence. Today, I’m excited to share that Greenlight Guru has acquired Enzyme, a modern quality management system (QMS) company for life sciences organizations. Founded in 2017, Enzyme has helped life sciences companies bring safe, effective products to market.
The 5 most common clinical data pitfalls in 2025 (and how to avoid them)
The methods and practices you use for collecting and managing clinical data will ultimately make or break the success of any clinical trial. A study may have an excellent design that’s executed flawlessly by each clinical site, but if there are errors in data collection, or the collection methods are not compliant with regulations, the sponsor may not be able to use that data in their regulatory submissions.
Opið bréf til Loga Einarssonar
Kæri Logi, Ég hef satt best að segja nokkrar áhyggjur af stöðu mála í nýsköpunar- og sprotaumhverfinu - þá sérstaklega eftir að tillögur um hagræðingar í ríkisrekstri voru kynntar fyrr í vikunni. Ég hef miklar áhyggjur af fjármögnunarmöguleikum fyrir sprotafyrirtæki ef vikið er frá nýsköpunarstefnu Íslands og kalla eftir uppfærslu á stefnunni. Ennfremur, kalla ég eftir því að hagræðingartillaga um að leggja niður Nýsköpunarsjóðinn Kríu (NSK) verði alfarið tekin af borðinu hjá ríkisstjórninni.
Ert þú engill? - Vísir
Englafjárfestar, eða „viðskiptaenglar“, eru hugtök sem sumir hafa heyrt um, en fæstir vita nákvæmlega í hverju það felst. Englafjárfestar eru einstaklingar sem leggja fjármagn í fyrirtæki, oft á byrjunarstigi, með það að markmiði að styðja við nýjar hugmyndir og frumkvöðla sem geta verið að þróa spennandi tækifæri.
Improving Clinical Data Collection with Effective eCRF Completion Guidelines
In clinical trials, study personnel use case report forms (CRFs) to standardize the collection of clinical data from study participants. This makes the CRF one of the most important documents in a clinical trial, as the design and content of a CRF can affect the quality and reliability of the data collected from participants. While CRFs have been created as paper documents in the past, today, the accuracy and ease of electronic case report forms (eCRFs) mean they are often used instead of paper.
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