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.
 
The software allows the proper management of resources and documents and an unlimited number of users can use it simultaneously. One can save or distribute a wide variety of documents, regardless of their sizes, and manage documents using workflows which are tailored to customer requirements and its ECO procedure (from small start-ups to large companies).
The work is conducted using an advanced Gantt, which presents the current progress of the project. At every step, the manager can see the progress of the development and the estimated date for completion of tasks.
Almond® allows change control and document control management, BOM history management while also being in compliance with regulatory requirements in accordance with the following standards:
  • ISO 13485 – Medical devices -- Quality management systems -- Requirements for regulatory purposes –with special considerations to Part 7.3 - Design & Development
  • 21 CFR Part 820 –Quality System Regulations, with special considerations to Part 820.30 – Design Controls
  • 21 CFR Part 11
    Almond software helps you get your design control under control!

Almond® was established following many years of experience in consulting and accompanying the development processes of medical devices by Gsap; Each company defined their own development process flow, the common difficulty was documenting these development process in compliance with the regulatory requirements.
This difficulty led to the conclusion that there is a great need for a tool to support and guide the development process and allow engineers to focus and move forward quickly with the development process.

Almond is a smart development tool with the following advantages:

  • The system ensures safe storage and quick retrieval of development documents.
  • Easy and short software implementation.
  • The software guides the development team through the development phases.
  • The program prevents errors (providing reliable information and prevents the use of wrong documents).
  • The program can be used to prove compliance with regulatory requirements during an inspection.
  • The documents are approved using electronic signatures – no papers or storage space required!

Almond accelerates the flow of information in the development process, thereby bringing brilliant ideas faster to your patients!