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.


Interactive Gantt Chart (exclusive)
Requirements and Traceability
Document Control
Change Orders Management
CAPA Management
Post-Market Surveillance
Training Management


21 CFR Part 11

21 CFR Part 820

ISO 13485:2016

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