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
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
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..
Cyber Security
- Site & Risk Assessments – Entails 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.
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
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
Auditing
Conducting and preparing for
- Internal / Mock Audits
- Support during external audits
- Clinical audits
- Suppliers audit
Statistics Strategy
- 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
Cyber Security
- Secure Product Development Framework / Secure Software Development Lifecycle (SSDLC)
- Secure device design / Secure by design
- Conducting Medical Cybersecurity review
- Prepare the documentation required according to the Cybersecurity regulatory guidelines
- Vulnerability assessments, perform Infrastructure, application, and product Penetration Test
- Establish the Cybersecurity risk assessment
- 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.
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.
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.