Purpose-built for Medical Device Compliance.
Selida is a comprehensive software solution designed to accelerate equipment implementation throughout simple and quick document generation and corresponding services. Developed and maintained in Switzerland, Selida follows the highest standards of precision and regulatory quality. Our software helps you achieve compliance, improve efficiency, and maintain data integrity.
Every module is aligned with the latest global standards and guidelines — ISO 13485 and FDA 21 CFR 820, ISO 2859, ISO 16269, ISO 7870, GHTF/SG3/Process Validation and other theme specific documents - ensuring regulatory compliance from equipment installation qualification (eIQ) to process performance qualification (pPQ).
Selida was built for small and mid-sized medical device manufacturers who need robust validation documentation without complex enterprise software.
Fast onboarding, minimal training, and intuitive design mean your engineers can focus on innovation, not paperwork.
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 and predefined fields for 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
ISO 7870
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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No external statistician needed — the logic is already inside Selida
Smart Statistics - Without the Headache.
Selida applies statistical methods automatically according to your data type — continuous and binominal data types (AQL and LQ), known or unknown data distribution settings.
It calculates sample plans for testing and manufacturing, generates control and run charts on the fly, ensuring your validation protocols and reports with processed data meet ISO and FDA expectations.
I work as a QA engineer, and most of my week used to go into preparing OQ and PQ validation protocols. Between Excel, Minitab, and Word templates, I’d lose days aligning sample sizes and statistical justifications. Auditors often pointed out inconsistencies. With Selida, everything changed: the system auto-populates protocols, calculates sampling with regards of confidence levels, and generates reports that are statistically sound. What used to take a week now takes half a day.
QA Engineer
Our consulting services
Support in consultancy services related to
Equipment Qualification (eIQ, eOQ) and Process Validation (pOQ, pPQ)
Equipment implementation and process development
Feel free to reach out for all other manufacturing and QMS topics,
so we can connect you with our trusted partners
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 needed and only keep the essential to comply with the requirements, always with patient safety and innovation in mind.
News
Equipment Qualification (EQ) and Process Validation (PV) modules (including protocol and report generation modules) available for trial users.
