Software Development & Regulation for
Medical, Health & Pharma Industries

MedDev Soft is a dynamic, innovative company bringing together hands-on experience and knowledge in medical and pharma software development and regulation solutions. Read More…

Our solutions fit any of your needs
One Stop Shop for Medical, Digital Health and Pharma Needs
Full Turnkey Solution
If you are CEO of start-up or SME company, this solution might fit you. Try it….
What is the output?
  • Save the development costs by developing the software product following regulatory requirements and all relevant documentation.
  • Fast regulatory certification of the quality and well documented product
  • Fast prototype development aimed architecturally to final product
  • Our team becomes part of your team during working on the projecy - involvement and caring.
  • All source code and documentation is your sole IP and belongs to you in terms of rights
  • Long-term support and continued development for advanced versions

What we offer?
  • One stop shop solution from proof of concept through prototype to final project through all development stages:
    • Medical and Pharma software lifecycle procedures
    • Software product requirements specifications
    • Risk, safety and hazard management
    • Software architecture and algorithms
    • Software development
    • Software SQA, validation & verification
    • Full software documentation according to FDA/CE standards
  • All these for any infrastructure started as PC, Mobile, Cloud, etc.

How we do it?
  • With a team of veteran engineers experienced in medical devices development
  • We have a software infrastructure product for the rapid development of medical software systems, which can be integrated to any medical device product.
  • Choosing the right, advanced but tested technologies and tools suitable for work
  • We doing the best for compliance with short timetables while maintaining strict quality.
  • Up-to-date knowledge of procedures and standards
  • Implementation of projects in all medical devices ranging from giant scanners with imaging algorithms, applications to physicians, interfacing with hardware and multi-disciplinary systems
  • All projects we have performed have received FDA and / or CE approvals
Full Software Life Cycle Solution
Are you VP R&D of medical device or digital health company and looking for the best solution? Try us….
What is the output?
  • Reducing time to “Go to Release” with maximum efficiency during the development
  • Fast, high-quality and documented software development from the definition stage up to validation
  • Expanding the development team for the project and adding responsible and caring people.
  • Full technical support for the code developed and future development.
  • Building a stable bridge between development and regulatory team – we understand both product and development needs as well as regulatory and documentation needs.

What we offer?
  • Developing Taylor made code according to project needs and regulatory requirements
  • Integration of a infrastructure software product for the rapid development of medical software systems, including DICOM libraries/Viewer, logging service and others.
  • Ongoing and post development software support
  • System Engineering and Software Quality Assurance full support

How we do it?
  • We have a large, professional and experienced programmers team with various expertise
  • The project is be developed by more than one programmer and supervised and leaded by CTO
  • We are a company and not one man show, there is always back fall
  • We have the ability to expand or reduce the manpower in the project according to needs.
  • At the same time, at least one programmer will be dedicated solely to the project
  • Ready infrastructure for developing multi-disciplinary systems for integration into your software
  • Full flexibility and adaptation to the company's needs
  • Specialization in a variety of technologies
Always on Time and on Budget
For PMOs that are standing in tight time and budget, we can offer your you…
What is the output?
  • Software development without doubling the cost to comply with regulation
  • Developing prototypes with an architecture thinking for a final product
  • Full transparency of the development process
  • Knowledge passes to the client in a clear and documented manner
  • A bridge between a development team and regulation
  • Full technical support for the code developed and future development

What we offer?
  • Strict project management while meeting budget and timetables
  • Fast and quality development and regulation
  • Development of tailor made software code meeting both product and regulatory requirements
  • Methodical and innovative Software development from preliminary requirements to final validation

How we do it?
  • Working closely with the client, regular meetings, integration on client sites
  • Strict work – all documentation sent to the customer after review by senior quality person
  • The project is be developed by more than one programmer and supervised and leaded by CTO
  • We are a company and not one man show, there is always back fall
  • Ready infrastructure for developing multi-disciplinary systems for integration into your software
From Fast Prototype to Final Product
If you are an entrepreneur of great medical, health or pharma idea, these services might fit you. Try it….
What is the output?
  • Fast and low cost prototype development
  • Saving money and time by preventing errors and obstacles on the way and by technological infrastructure
  • Share with you our broad knowledge about the market and the players in the field.
  • We will provide you with echo system suppliers (e.g. with complementary services in the field)

What we offer?
  • Consulting of the first steps in the medical/health/pharma world
  • Plan and implement the right development process to ensure economical and best performance of your products
  • Product prototype development
  • Facilitating and reducing development and regulatory costs.
  • Hands-on and consulting services throughout the entire product lifecycle, from ideation, development to regulation

How we do it?
  • Hands-on fast technological software development and regulation solutions
  • Technological infrastructure for rapid product development processes
Software Quality Assurance and Regulation
QA/RA people, we have a great solution for your needs. Check what can we offer you…
What is the output?
  • Establish a compliant organizational conduct to meet the highest standards and regulations
  • ISO-based quality assurance and risk assessment procedures
  • Regulatory software strategy for medical and pharma systems
  • Guided development team with knowledge and compliance with regulatory standards.
  • Software development procedures throughout the life cycle and supporting software validation procedures.
  • Set of TEMPLATES for all software documents and software development / validation procedures

What we offer?
  • Full Software Quality Assurance Services
  • GAMP compliance
  • Software validation & verification according to FDA/CE requirements validated to fulfil all regulatory expectations
  • Risk, safety and hazard management
  • Business Process Management for Pharmaceuticals & Life Sciences
  • Software development lifecycle procedures
  • Validation of QMS systems and supporting / non-product software according to ISO13485
  • Validation of any process based on software systems
  • Off-the-shelf software validation / procedures
  • Usability Tests
  • HIPAA Compliance
  • GDPR Compliance
  • CFR 21 Part 11 Compliance
  • MDSAP procedures and documentation
  • Consulting for software compliance services
  • Verifying software
  • Preparation of all required documentation for CE / FDA / CFDA
  • ISO 27799 ISMS for healthcare
  • ISO 27001 Security
  • CYBERSECURITY procedures and compliance with them
  • CHECKLISTS for:
    • HIPAA
    • CYBERSECURITY
    • IEC-62304
    • IEC-60601 for software

How we do it?
  • Wide experience with regulation requirements
  • We will be a bridge between development and regulation while doing actual work and not just consulting.
  • We have received regulatory approvals for dozens of medical companies
Consulting and Hands-on Solutions
For software engineers, testers, and field people in medical or pharma, check how can we help you….
What is the output?
  • A knowledge center on any technological topic for getting quick and expertized answers. For example:
    • Is certain operating system preferred on other for the medical systems?
    • Can Open Source be used in development of medical systems?
    • How do you write medical software documents?
    • What is the difference between VALIDATION and VERIFICATIONS?
    • What are software risks?
    • How to develop software and not double development cost for comply with regulation?
  • Extensive knowledge on software testing and regulation compliance

What we offer?
  • Technical and professional knowledge center for managers and field-personnel.
  • Courses of software quality for medical systems
  • Courses for compliance with regulatory requirements
  • Checklist for Cyber/HIPAA/GDPR compliance
  • Templates and procedures.

How we do it?
  • Hands-on and consulting services throughout the entire product lifecycle, from ideation, development to regulation.
  • Procedures for the development of medical software
  • TEMPLATES for medical software lifecycle
  • Multithreading infrastructure for rapid construction of multi-modular systems with interfaces and other systems
  • DICOM / HL7 development libraries

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OUR TEAM

Dina Sifri

CEO & FOUNDER
Mrs. Sifri brings over decade of experience in software engineering for medical device and pharma companies aside to academic degrees in relevant fields.

Oren Sifri

CTO
Mr. Sifri brings over decade of experience in software architecture and engineering in wide range of companies aside to academic degrees in computer science.

Grace Feldman

SQA MANAGER
Mrs. Feldman brings over decades of gained experience in various domains of software quality engineering in medical fields and healthcare systems.
All Team

TESTIMONIALS

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