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ISO Certifications at ScienceSoft

ScienceSoft’s ISO 9001, ISO/IEC 27001, ISO/IEC 27701, and ISO 13485 certifications reflect independently audited practices for quality, information security, privacy management, and medical software development.

ISO Certifications at ScienceSoft
ISO Certifications at ScienceSoft

For companies evaluating an IT vendor, certifications provide an objective way to assess operational maturity and reliability. At ScienceSoft, our ISO certifications confirm that our operational practices are independently audited, standardized, and continuously improved.

ScienceSoft holds the following certifications:

Certified scope

Certificate

ISO 9001:2015

Quality management system for software design, development, and technical support.

ISO/IEC 27001:2022

Information security management system for software design, development, and technical support.

ISO/IEC 27701:2019
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ISO/IEC 27701:2019 has been replaced by ISO/IEC 27701:2025. Existing 2019 certificates remain valid during the transition period, which is expected to run until 2028. ScienceSoft plans to transition to the 2025 edition during the next certification cycle.

Privacy information management system, extending ISO/IEC 27001 to personal data collected, processed, and stored in software design, development, and technical support.

ISO 13485:2016

Quality management system for the design, development, and technical support of software for medical systems, medical diagnosis, and medical platforms.

For RFPs, vendor due diligence, or security reviews, ScienceSoft can provide additional certification details or supporting documentation upon request.

 

Why ISO Certifications Matter When Choosing a Vendor

For enterprises, government organizations, software vendors, and companies in regulated sectors such as healthcare and finance, ISO certifications help reduce uncertainty during vendor evaluation. They provide an objective way to check whether a vendor’s quality, security, and compliance-related processes are formalized, audited, and continuously improved.

Working with an ISO-certified IT vendor gives you:

  • A documented delivery framework instead of ad hoc execution.
  • Independently audited quality and security management practices.
  • Clearer rules for handling requirements, changes, risks, incidents, and documentation.
  • A stronger basis for RFPs, supplier risk assessments, and compliance-sensitive projects.

 

Our ISO Certifications Explained

ISO 9001: Quality management for software delivery

ScienceSoft’s ISO 9001-certified quality management system applies to software design, development, and technical support. In client projects, this means ScienceSoft follows defined processes for planning, requirements management, delivery control, quality assurance, issue handling, and continuous improvement.

What it means for you:

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ISO 27001: Information security management for software delivery

ScienceSoft’s ISO/IEC 27001-certified information security management system applies to software design, development, and technical support. It provides a structured framework for managing information security risks and protecting client data, intellectual property, project assets, and collaboration environments.

What it means for you:

  • Security practices can be reviewed during vendor due diligence and RFPs, and security responsibilities are clearer from the start of cooperation.
  • Client data and project assets are handled under documented procedures.
  • Project teams work within a formal information security management framework.
  • The information security management system is independently audited within the certified scope.
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ISO/IEC 27701: Privacy information management for software delivery

ISO/IEC 27701 extends ISO/IEC 27001 with privacy-specific requirements. While ISO/IEC 27001 focuses on information security management, ISO/IEC 27701 focuses on how personal data is collected, processed, stored, and governed. The certification is especially relevant for projects involving customer, patient, employee, user, or citizen data, including projects subject to GDPR and other privacy regulations.

ScienceSoft’s ISO/IEC 27701-certified privacy information management system applies to software design, development, and technical support.

What it means for you:

  • Personal data is handled within a structured privacy management framework, not only a security framework.
  • Privacy roles and responsibilities are clearer across software delivery and support activities.
  • Data collection, processing, and storage activities follow documented privacy management rules.
  • Privacy risks are identified, assessed, and managed alongside information security risks.
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ISO 13485: Quality management for medical device software

ScienceSoft’s ISO 13485-certified quality management system covers the design, development, and technical support of software for medical-device-related use cases.

ISO 13485 is internationally recognized as a regulatory QMS foundation for medical devices: FDA’s Quality Management System Regulation incorporates ISO 13485:2016 by reference, while in the EU, EN ISO 13485 is used as a harmonized standard under medical device regulations.

What it means for you:

  • Development practices are aligned with medical device software quality management expectations.
  • Requirements, risks, changes, and documentation are handled through a controlled process.
  • Traceability and validation activities are easier to plan and maintain throughout the software lifecycle.
  • Project teams work within a quality management framework suitable for compliance-sensitive medical software.
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How We Apply ISO-Certified Practices in Real Projects

Team Augmentation for an HIE Platform Provider

ScienceSoft was chosen for its ISO 9001, 27001, and 13485 certifications. The client received a secure PHI de-identification module that supports full and partial data anonymization and controlled data sharing across healthcare organizations.

SaaS Quality Management System for Manufacturing Supply Chains

Under its ISO 9001-certified quality management system, ScienceSoft re-engineered a legacy QMS prototype into a multi-tenant SaaS product. The MVP was launched in 3 months, followed by the full release in under 7 months.

ISO 13485-Compliant Laboratory Diagnostics Software Delivered in 7 Months

ScienceSoft developed laboratory diagnostics software under ISO 13485 and related medical software standards. The solution validates genetic test data, interprets results, integrates with LIMS, and includes risk, traceability, and CE marking documentation.

Regular Pentesting for a Global Asset Management Company

An ISO 27001-certified vendor was a key requirement for the client. ScienceSoft’s recurring penetration testing helped validate the security of the client’s web application and network after system updates and provided audit-ready reports and attestation materials.

RPM Web Dashboard Powered by Wearable ECG Sensors

A remote cardiac monitoring software provider chose ScienceSoft for ISO 13485 and ISO 27001-certified quality and security management. The delivered dashboard enables secure ECG data access, supports HIPAA and GDPR compliance, and helps reduce ECG data storage costs.

Lung Cancer Detection Application for Bioaffinity Technologies

ScienceSoft developed medical device software under an ISO 13485-certified quality management system. The solution enables lung cancer detection, supports secure HL7-based data exchange, and includes documentation for regulatory submission.

Clients About ScienceSoft as an ISO-Certified Vendor

Star Star Star Star Star

Our major vendor selection criteria included solid experience in QRadar deployment, customization, and configuration for banking and financial companies, an ISO 9001 certified corporate quality management system, Silver/Gold IBM Business Partner status, and IBM Certified Associates on board. ScienceSoft fully complied with all the criteria, so we commissioned the company to carry out QRadar implementation and support. The implementation project was delivered on time and budget.

We first came across ScienceSoft when we were looking for a pentesting vendor to perform regular checkups of our apps. Their team did an amazing job during the first engagement, and we haven’t had to look for another security vendor since.

Plus, like Interprefy, ScienceSoft has an ISO 27001 certification, so we felt secure giving their team access to our environment for gray-box testing. We are happy to recommend ScienceSoft for penetration testing and will definitely continue to engage their team for our security initiatives.

During our cooperation, ScienceSoft proved to have vast expertise in the Healthcare and Life Science industries related to development of desktop software connected to laboratory equipment, a mobile application, and a data analytics platform. They bring top quality talents and deep knowledge of IT technologies and approaches in accordance with ISO 13485 and IEC 62304 standards.

FAQs About ISO Certifications

Do ISO certifications guarantee project success?

No, ISO certifications do not guarantee project success on their own. What they do show is that the vendor works within documented, independently audited management systems for quality, security, or medical device software quality management.

Project success also depends on technical expertise, domain knowledge, project governance, stakeholder involvement, and realistic scope management.

How can we verify ScienceSoft’s ISO certificates?

ScienceSoft’s current ISO certificates are published on this page. They show the certified scope, issuing body, covered locations and entities, certificate number, and validity period. The certificates are issued by LL-C (Certification), an international certification body, and include validity codes that you can verify via LL-C’s verification portal.

For RFPs, vendor due diligence, or security reviews, ScienceSoft can provide additional certification details or supporting documentation upon request.

Do these certifications apply to my project?

ScienceSoft’s ISO certificates cover the core software delivery activities shown in the certificate scopes: software design, development, and technical support.

This means that projects involving these activities are managed within the relevant certified systems: ISO 9001 for quality management, ISO/IEC 27001 and 27701 for information security and privacy management, and ISO 13485 for medical device software quality management.

For projects with additional security, procurement, or regulatory requirements, ScienceSoft clarifies the needed controls, documentation, and contractual commitments during vendor evaluation or project planning.