ISO 27001 Implementation for SaMD Company

PROBLEM STATEMENT

A Software as a Medical Device (SaMD) company developing healthcare applications and web portals required ISO 27001 certification to ensure the security and privacy of sensitive healthcare data. As their solutions handled confidential patient information, compliance with information security standards was critical to meet regulatory requirements and gain customer trust.

Our Approach

Gap Analysis: D2R conducted a gap analysis to identify risks in current data security practices.
Developed and implemented a tailored Information Security Management System (ISMS), including policies for data access, risk management, and incident response.
Set up robust controls such as data encryption, secure transmission, and real-time monitoring.
Prepared the company for the ISO 27001 audit, leading to successful certification.

Outcome

The company achieved ISO 27001 certification, demonstrating its commitment to safeguarding patient data and meeting global data privacy and security standards. This certification not only enhanced the company’s credibility but also enabled compliance with regulatory frameworks, fostering trust among healthcare providers and patients.

Case Studies

Shopping cart

ISO 27001 Implementation for SaMD Company

PROBLEM STATEMENT

Our Approach

Outcome

You Need Help?

Key Cybersecurity Documents for SaMD FDA

Biocompatibility – The Unseen Backbone of