medical device Solution
Efficient development process
The software guides the development team through the development phases
Safe and Quick
The system ensures safe storage and quick retrieval of development documents.
Electronic Signatures
The documents are approved using electronic signatures – no papers or storage space required.
Tested and validated by 21 CFR Part 11.
Any place, any time
Be Always up to date.
Automatically updated Interactive Gantt view for each project
Short Implementation
Easy and short self implementation
By Videos and step by step guides.
Get The Right Version
Preventing using wrong versions of document, forms, template etc.
Control your design process with a SMART, FAST and EFFICIENT software
About Us
Almond® is a tool for managing the development of medical devices, that can save up to 2 years in the design and development process of medical device products; all in a secure cloud environment.
Almond® leads the development process while ensuring compliance with regulatory requirements (21 CFR Part 11, ISO 13485:2016 and 21 CFR Part 820), maintaining the development history and indexing for all documents to enable quick and easy access to all files based on authorizations.
Almond® was established after many years consulting and accompanying the development process for numerous medical device companies with Gsap®, a leading consultation company in the medical device space.
Almond® is dedicated entirely to management of the medical device development process.
MAIN MODULES
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Interactive Gantt Chart (exclusive) |
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Requirements and Traceability |
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Document Control |
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Change Orders Management |
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CAPA Management |
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Post-Market Surveillance |
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Training Management |
COMPLIANCE WITH
21 CFR Part 11
21 CFR Part 820
ISO 13485:2016