E-Health and digital health regulatory strategy, classification, trends and challenges
General Information:
Course scope: 18 hours (9:00-17:00)
Course type: Frontal + remote
Location: Science park, Rehovot
Lecturer name: Eran Yona
Medical software, cellular application, telephone / digital medicine, wearable equipment, or any other digital health device used for sensing, monitoring, testing, analyzing, drawing conclusions or supporting medical staff decisions may have an impact on the health of the user and may, therefore, be considered At the regulatory level as a medical device and therefore strict compliance with regulatory requirements.
The various digital health products are divided into categories, depending on the level of risk they represent and hence the regulatory requirements on the subject are also set. In order to obtain the approval of the health authorities, the most appropriate category must be selected, according to which the product will be classified as well as its registration route.
The process of registering a digital health product / digital product requires resources of time, money and knowledge. Therefore, awareness and compliance with regulatory requirements in advance, while understanding the limitations and limitations and preparation of relevant documents ahead of time, can save the company valuable time and unnecessary increases.
Course Content:
- The Digital Health new era
- Digital health and E-health technologies and products from various fields
- What are the relevant questions to be asked as part of the development process?
- What are the principles for determining the risk level of the product?
- What questions should be asked to choose the most appropriate regulatory pathway?
- What should be included in the classification rational?
- Understand the basic regulatory requirements of each classification
- What is QMS?
- Understanding the basic principles of HIPAA and GDPR for patient information confidentiality
- Risk Assessment
- Future trends and challenges in the E-health industry
Our consulting services
Research and development
Consulting in a variety of areas, including design, research laboratories and clean rooms, development technologies, investor business presentations, regulatory strategies, market analysis, clinical trial protocols, GLP, GCP, ISO 17025, calibration, CMC and professional training.
Design and engineering
Designing factories, clean rooms and laboratories, engineering documentation, certification, technology selection, process engineering, and validation, with a combination of theoretical knowledge, practical experience, and in-depth understanding of biomed regulations and in accordance with GxP principles.
Manufacture and packaging
Consulting on manufacturing plant design, manufacturing process development and engineering, selecting the most appropriate technology, process scale-up, technology transfer, GMP, process improvement, yield optimization and improvement, employee training, validation of equipment, systems, and production and cleaning processes.
GxP, quality and validation
Advises, establishes, accompanies and upgrades various types of quality management systems, offers GMP training and courses, coordinates adoption of GxP principles, ISO 13485, quality assurance and preparation for global regulatory audits while conducting risk analysis and evaluation, and verification and validation of equipment, systems, software, test methods, manufacturing and cleaning processes, until a successful audit outcome is obtained.
Regulation and registration
Regulatory consulting and drug registration, medical devices, CE mark, dietary/nutritional supplements and cosmetics in Israel and worldwide, building a smart regulatory strategy, helping to prepare documents and meet requirements in a professional manner, in a short time, product labeling, shelf life and graphics, import licenses and meetings with regulatory bodies, until approval (marketing authorization) is received.
Software and systems
Digital healthcare consulting, software development and medical applications in accordance with US FDA 21 CFR part 11 / EU Annex 11 / US HIPAA / EU GDPR requirements, ISO 13485/ISO 27001/ISO 27799, CE marking, risk assessment, verification and validation of software and control systems until marketing authorization (approval) is obtained.