Quality & validation digital health2020-08-12T10:15:40+00:00

Quality, GxP & validation in the digital health field

E-health & Digital health is a subgroup belonging to the field of Medical Device, which develops medical devices, accessories and software for patient needs (whether for home care or use in hospitals and clinics).
Because digital products of this type are used to treat, among others, sick people, this industry is exposed to high risk, and as such is characterized by stringent levels of supervision and regulation, to maintain public health, while minimizing the chance and risk of harm to human life.

The field of quality system management as reflected in ISO 13485, ISO 27001, ISO 27799 and the GDPR, MHRA, HIPAA requirements effectively govern all processes involved in the development, production and accessibility of digital healthcare products to end customers.
The quality industry in the medical industry in general and digital health in particular is characterized by a high level of dynamism. Health authorities’ quality requirements and guidelines are constantly updated and updated to provide patients and patients with reliable, accurate, sensitive, high-quality, safe and reliable digital products.
Apart from the strict management and quality assurance and control field, the digital health industry is characterized by innovative technologies, which include infrastructures such as the 5th generation of cellular networks, sensing, monitoring and control systems, DL, AI, ML and data analysis tools, and therefore should meet the ordination tests. Part of the certification process includes validation and validation (V&V).
Proper verification/certification / validation, alongside an effective and functioning quality management system, will improve the reliability, accuracy and performance of the digital product, and its quality and ensure that the product successfully meets both user expectations and requirements dictated by health and regulatory authorities throughout its life cycle. Of the product.

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Quality, GxP & validation consulting services in the digital health field

  • Medical software and digital health global regulatory srategy

  • Medical software and E-health regulatory classification rationals

  • Medical software, E-Health, cellular application technical file

  • Digital health, E-health & medical software CE & 510K registration

  • E-Health & Medical software verification and validation (V&V)

  • Validation for medical cellular applications

  • Quality Management System establishment

  • ISO 13485 certification

  • FDA CFR 820 quality system

  • Policies and procedures writing

  • Design Control

  • HIPAA, SCO2, GDPR compliance

  • ISO 27001 and ISO 27799 certification

  • Clinical trials consultancy

  • Risk analysis and risk assessments

  • Device Maser Record (DMR)

  • DHF- Design History File

  • Compliance with FDA, ISO, CE guidelines and requirements

  • Software Quality Assurance (QA) and testing

  • Medical software/E-Health system validation for 21CFR part 11/Annex11 compliance

  • Internal audit, gap analysis and training towards FDA, ISO, NB, CE and HIPAA inspections

  • Clinical risk assessment and GCP

  • Digital health and medical courses & training

  • Data integrity and ALCOA

  • Medical regulation consulting

Other digital health services

Quality & validation digital health - Bio Chem
Quality & validation digital health - Bio Chem
Quality & validation digital health - Bio Chem
Quality & validation digital health - Bio Chem
Quality & validation digital health - Bio Chem

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