Software & systems in the Medical device field2020-08-12T10:12:29+00:00

Software & systems in the Medical device field

Provides consulting services in various fields to companies from the pharmaceutical, medical, food, digital health and dietary and cosmetics supplements.

 We advise and accompany our clients from the product development stage, selecting the most appropriate technology, building the product and technical portfolios, building the quality system, training and certifications, submitting to the health authorities and registering the product, and validation and verification, adapting the company to international GxP requirements and guidelines, solving technological problems and processes. In manufacturing, performing analysis and risk assessment, project management and more. We see great importance in providing a professional, cost-effective and efficient response to our customers and without compromise on quality issues. To contact us for an appointment please click here!

What customers think of us

Software & systems consulting services in the medical device filed

  • Global markets regulatory strategy

  • Medical software and cellular applications

  • HIPAA, SOC2 and GDPR compliance

  • Master documents and policies

  • Backup, restore and disaster recovery procedures

  • Compliance with 21CFR part 11 requirements

  • Compliance with Annex 11 requirements

  • Data Integrity and ALCOA

  • Digital Health

  • Software risk analysis and risk assessment

  • Preparations towards regulatory audits

  • Validation and verification of software and digital health apps

  • SAMD CE Mark and 510K FDA registration

  • ISO 27001 and ISO 27799 certification

  • ISO 13485 and ISO 14001 certification

  • DMR, DHF and technical file

  • Clinical Risk Assessment and GCP for SAMD

  • Medical software classification based on regulatory requirements

  • Digital health training and Software Validation courses

  • SAMD clinical trials

Other medical device services

You are invited to contact us

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