1Protech

25 Years of providing State of the art IT, Cyber Security & Medical regulation services to global companies and start-ups 

About us

1Protech is a boutique consultancy company specializing in the fields of IT, cyber security, and Medical regulation. Our team consists of highly experienced and talented consultants, each with over 20 years of experience and background in senior IT, information security, regulation, and accreditation positions in leading hi-tech companies in both Israel and globally, in various industries and sectors such as telecommunications, financial, intelligence, health, energy, government, ad-tech, and retail.

Our Offering

CISO as a Service

Taking charge of an organization’s entire security operation with professional Cyber Security personnel dedicated to providing the following: Strategy, Policies, Risk management, Business Continuity, Security design, AppSec & SSDLC, Cyber security consultancy, Privacy, Cyber security awareness & training, 3rd party security assessment / Supply chain assessments

Certification as a Service

Prepare your organization to successfully complete desired certification & accreditation audits. This service includes building internal processes, defining policies, guidelines, and evidence collection for:

Information security:
ISO 27001/ ISO 27002 / ISO 27017, SOC2, ISO 22301

Privacy: GDPR / CCPA / ISO 27018 / ISO 27701

Medical device: ISO 13485, HIPAA, FDA, CE

Risk Assessment as a Service

Providing a complete turnkey site & risk assessment service that includes: Risk assessment report, Risk ledger, Risk control matrix & KPIs, Vulnerability assessment, Penetration Test (PT), FDA & CE cyber security risk analysis

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Strategy & execution for engineering

Boost overworked engineering managers through consulting and strategic advisory to achieve high-performing organizations with the culture you aspire to have.

Leadership Boost
Engineering Boost
AI Boost
Peer Group Boost
CTO as a Service

 

IT & Cyber Services

IT Governance

  • Design, guide and assist in the implementation of governance processes to meet security compliance requirements, staying on top of security controls.
  • Business Continuity – A customized business continuity program involving all relevant parts and stakeholders within the organization to meet the required readiness level.
  • Certifications & Accreditations – IT preparation for Audit for various compliance requirements
  • Leading and managing the deployment of new technology solutions
  • Defining and leading the implementation of monitoring solutions and SOC services
  • Define and lead the deployment of information security solutions such as: Endpoint Security (to protect the end-users) computers, laptops, desktops, mobile devices, and servers, Network Access Control (NAC), and Identity Vulnerability Management, Zero Trust, Firewalls etc.
  •  Key Performance Indicator (KPI) – Develop and execute a systematic strategy to enhance the efficiency of business processes and controls.

Cyber Security

  • Business Impact Analysis (BIA) – we provide a comprehensive view of the organization by pinpointing critical business functions, processes, and dependencies. Holistic analysis that empowers proactive risk management and strategic decision-making.
  • Site & Risk Assessments – conduct comprehensive process providing detailed reports and mitigation plans for site and risk assessment. Establish effective risk management programs aligned with industry standards such as ISO27001, NIST CSF, and Service Organizational Controls (SOC2)
  • Vulnerability Assessment – A full cycle from a complete assessment to a detailed report containing remediation guidance.
  • Cyber Security Consultancy – designing comprehensive and effective security control measures such as endpoint and network security, email and web security, cloud security posture management, identity, access management security, and more.
  • CISO as a Service – Leading information and cyber security activities within your company, on-demand, on an hourly basis or fixed package, in accordance with your needs.
  • Observability – Establish and implement a consistent program to uphold the integrity of the information security process. 

Regulation

  • Certifications & Accreditations – Audit preparations and company readiness for various compliance requirements and standards such as ISO 27001, ISO27002, ISO27017, SOC2 audits, SOX ITGC requirements, and more.
  • Privacy Programs – Leading activities relating to privacy regulation requirements to comply with GDPR, ISDR, CCPA, ISO27018, ISO27701, ISO27799 or similar.
  • Policies – we provide custom-made security policies to meet compliance, helping your organization with the needed guidance for information security practices.

Solution Architect

  • Tailored strategy 
  • System design – decoupled architecture  
  • Data driven decision making
  • Roadmap execution
  • Cost Management Optimization
  • Technology selection 
  • Cloud architecture  
  • Private / Public Cloud transformation
  • Integrate CI/CD pipelines 
  • Observability, Logging, and monitoring
  • Microservices and containers – Kubernetes and Docker
  • Configuration Management
  • Unit and integration testing
  • Infrastructure as Code – DevOps culture
  • Team empowerment – recruiting and managing 
  • AI integration to level-up your Coding, Testing, Debugging and Documentation 

Medical Regulation

Quality

Leading and managing the deployment of Quality Management Systems (QMS) that comply with global regulatory requirements.

  • Quality Management System (QMS) implementation and certification
  • ISO13485 deployment 
  • Implementation of IEC 62304 requirements for software development
  • Privacy HIPAA, GDPR, PIPEDA, CCPA 
  • Definition of the work processes and procedures
  • Writing technical files
  • Risk management processes for medical devices based on ISO14971
  • Gap Analysis
  • FDA, CE, AMAR submission
  • Technical File and Design Dossier Support

Data science

  • Data scientist, data analysis and validation activities including extract, analyze and interpret large amounts of data from a range of sources, using algorithmic, data mining, artificial intelligence, machine learning, and statistical tools.
  • Development and evaluation of decision support systems, Artificial Intelligence (AI) / Machine Learning (ML).
  • Building optimization models that use technologies like NLP and ML to enhance processes.
  • Using Data-driven approach to improve accessibility/availability of healthcare services using.
  • Developing data-driven solutions and analytics
  • Management for the implementation of innovative technologies, decision support systems, workflow, diagnostic accuracy, resource use etc.
  • Diagnosis/monitoring solutions using AI/telehealth technologies to expand care access.

Statistics Strategy

  • Clinical research, clinical study protocols, clinical evidence generation, data analysis and reporting, academic publication, clinical evaluation planning and report, peer review assistance.
  • Strategic support to FDA IND to NDA and EMA Market authorizations
  • Fit for purpose phase I, II and III study designs
  • Sample size determination
  • Interim analysis for efficacy and futility
  • sample size re-calculation
  • Adaptive and Complex Innovative designs
  • Statistics support to Independent Data and Safety Monitoring Boards

Auditing

Conducting and preparing for:

  • Internal / Mock Audits
  • Support during external audits
  • Clinical audits
  • ISO 27001 / SOC2 
  • Suppliers audit

Cyber Security

  • Secure device design / Secure by design 
  • Threat Modeling in Medical Devices
  • Secure Product Development Framework / Secure Software Development Lifecycle (SSDLC)
  • Establish the Cybersecurity risk assessment based on NIST best practices, perform an assessment including software bill of materials (SBOM).
  • Cybersecurity testing Vulnerability assessments, perform Infrastructure,  application, and product Penetration Test
  • AI integration to level-up your Coding, Testing, Debugging and Documentation 
  • Conducting Medical Cybersecurity review
  • Prepare the documentation required according to the Cybersecurity regulatory guidelines   
  • Prepare a Cybersecurity mitigation plan
  • Provide security guidelines according to findings

Meet Our Team

Mor Sharon

CO-FOUNDER & CEO

A medical regulatory expert with over a decade of experience in managing complex processes with various teams across multiple disciplines. Mor is a unique specialist in her field, leading in all matters regulatory at the highest national level. Over the course of her career, Mor worked and maintained a close relationship with international accreditation bodies such as JCI, Accreditation Canada, Australia NSQHS and ISQua, and more, and is the founder of the national knowledge center at the Israeli ministry of health.

Dr. Mor Saban

Head of data science

A certified data scientist and a nurse with an extensive clinical education, that includes three master’s degrees in healthcare science and a Ph.D. in emergency medicine, Dr. Saban is an expert in health policy, data-driven research, and technology assessment in healthcare. Having gained considerable knowledge and expertise during tenures at the Gartner Institute and the Israeli Ministry of Health, Dr. Saban valuable research and data knowhow and insights that are crucial for integrating cutting-edge technologies into clinical workflows

Yochanan Sharon

CO-FOUNDER & COO

With a proven track record of more than 25 years in operations, IT infrastructure, and Information security in global companies, specializing in high-tech & R&D environments, as well as government organizations. Over the last 15 years Yochanan specialized in taking full responsibility as CIO and CISO in startup companies leading the operation, IT, DevOps, and cyber security solutions all the way to unicorn status.

Yair Alerganti

Head of Clinical and Research

Yair specializes in clinical trials of investigational medicinal products and can provide a complete range of regulatory, QA, data management, biostatistics analysis in addition to clinical management and lead products through 510K approval and CE Mark. Yair addresses all clinical study types, in all stages and phases, using advanced and controlled methods and delivering high quality services. Yair holds a bachelor’s degree in biology and studies of Pharmacoepidemiology, both from Ben-Gurion University at the Negev.

Mor Asher

HEAD OF CYBER SECURITY

An experienced Information Security Leader with over 20 years of experience. Mor specializes in InfoSec strategy, enterprise risk management, security design and architecture, business continuity, SOC, SIEM and incident management, GRC, SSDLC and AppSec, vulnerability and cloud security posture management, microservices, containers, and serverless security. A compliance expert in ISO 27001/27017, 22301 / GDPR / PCI-DSS / SOC (1/2) / SOX (ITGC) certifications.

Matan Kubovsky

Owner of Matan K. Consulting

Matan K. Consulting helps build better RnD Organizations. With vast experience of more than 15 years as CTO and Consultant, Matan is helping CTOs and VP Engs to supercharge their skills and performances of their teams, via mentorship and practical tools. Example Service include building secure SDLC, Technical Vulnerability Management, Policies and many more.

Europe Office: +357-97537318 /9
Israel Office: +972-73-7262464
eMail: Office@1-protech.com

Contact Us