We have the solution for you.
Standardisation

Templates aligned with industry requirements for qualification and process validation (IQ OQ PQ)
ISO 13485
21CFR820
Flexibility

Adaptable to your internal QMS
Fits the needs of every department for enhanced communication: QA, RA, RD, and PRD
Speed

Work faster and smarter
Auto-population of sections for a quicker document generation
Testing groups

All variabilities taken into account
Includes process parameters, testing methods, data types and others
Sample size

Calculated automatically by the system
ISO 2859
ISO 16269
Cost reduction

Automatisation of process
No deep statistical knowledge needed
Document templates
Stastistical analysis
Beginner friendly
Medical device specific
Maximal flexibility
Selida
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Statistical packages
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Document generators
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Story
Based in Switzerland, and born from the collaboration of a RD and a QA engineer, the founders' expertise in the medical device industry allowed them to create a solid solution and share it with other professionals.
Vision
The goal is to ease documentation creation, make it accessible to all, especially small to medium sizes companies, and
become the benchmark in regulated industries.
Core principles
Simplify as much as possible and only keep the essential to comply with the requirements, always with patient safety and innovation in mind.
News
Prototype with IQ, OQ, PQ modules available now for demo.
Further modules currently in development.
Broad range of consulting services now available for medical devices QMS topics.