Defend, Detect, Defeat:

Our Commitment to Cybersecurity Excellence

We are

IT Compliance and Cybersecurity team

We are here to help projects to be compliant with applicable regulations security standards

You can contact us with

✉️ admin@onidef.com

IT Compliance & Cybersecurity

Compliance

  • QMS &ISMS development

  • Data protection and privacy (GDPR, HIPAA)

  • Technical file development

  • Security audits

Expertise

Process engineering with regulatory compliance for complex product design, development, testing, verification and validation, maintenance and support

Cybersecurity

The practice of protecting systems, networks, and programs from digital attacks that aims to prevent or minimize the damage caused by cyberattacks, such as data breaches, ransomware, identity theft, or sabotage

Types of engagement

  • Ensure development under Client-specified regulatory, processes and procedures

  • Ensure development under Onidef QMS regulations

Our services

Develop, implement processes for regulatory purposes of a project:

  • Based on Onidef's regulations

  • Based on Customer's requirements
    Based on merged and adopted mutual requirements

QMS regulations

Process implementation

  • Develop appropriate changes in processes and procedures

  • Provide consultations how to implement them

GAP analysis

Perform processes and procedures gap analysis with applicable regulations

Security testing

  • Penetration testing

  • Web application security testing

  • API security testing

  • Application security testing

  • Vulnerabilities management

Trainings

  • Provide set of trainings about practical compliance in development projects

  • Provide presentation of Onidef's QMS and compliance experience

Standard highlights

QMS & ISMS

Deep knowledge in QMS&ISMS: ISO 13485, ISO 9001, ISO 27001 standards, and CFR 21 part 820

Experience with external & internal audit preparation

Risk Management

Onidef regulations to perform product

Risk Management activities based on ISO 14971, FMEA, IEC 61025 (FTA)

Regulations

Experience with GDPR. NIST & HIPPA

Security experience

Experience with NIST, TISAX, SOC 2 Type 1, 2, COBIT, NIST

Software compliance

Onidef regulations to perform Software design, development, testing, maintenance and support and stay within IEC 62304 standard

Usability engineering

Onidef regulations to perform Usability engineering activities based on IEC 62366, HF FDA guidance