Our operations adhere to and encompass a comprehensive understanding of:

ISO 13485:2016, a benchmark standard for quality management systems in the realm of medical devices.
ISO 9001, another crucial quality management standard that forms the foundation for consistent and customer-focused performance.
ISO 27001:2017, a framework for establishing, implementing, maintaining, and continually enhancing an Information Security Management System (ISMS).
Additionally, our adherence extends to IEC 62304 compliance, a cornerstone for the adherence to Medical Device Software Lifecycle Processes.

These standards not only guide our approach but underscore our commitment to maintaining the highest levels of quality, security, and compliance across all aspects of our operations.

qointa's solutions have been meticulously crafted to align with industry guidelines, the EU Data Protection Act, and the US Safe Harbor guidelines for data protection.

This comprehensive compliance encompasses:

Directive 95/46/EC, a pivotal regulation safeguarding individuals in the processing of their personal data and its unrestricted movement.

COMMISSION DECISION 2002/16/EC, establishing standard contractual clauses for the secure transfer of personal data to processors in third countries, within the framework of Directive 95/46/EC.

Directive 2002/58/EC, which addresses data protection and privacy in the domain of electronic communications, adapting the principles of Directive 95/46/EC to the evolving landscape of telecommunications.

45 CFR Parts 160/164, delineating the HHS Standards for Privacy of Individually Identifiable Health Information, Health Information Security Standards for Electronic Protected Health Information Protection, and the broader administrative requirements, including procedures for investigations, penalties, and hearings.

HIPAA regulations ensure that our technologies guarantee patient confidentiality while offering authorized sponsor access to necessary data through limited, authorized login/registration features.

BC 5701, embodying GDPR (General Data Protection Regulation) standards that establish comprehensive data protection regulations.

Through our meticulous adherence to these regulations and guidelines, we ensure the highest level of data protection and privacy across all our solutions.

We are registered and well-versed in a comprehensive array of regulatory rules and guidelines, including:

Regulatory Frameworks:

MDR (Medical Devices Regulation)
IVDR (In Vitro Diagnostic Medical Devices Regulation)
FDA Regulations:
- Title 21 of the Code of Federal Regulations (CFR), specifically Part 820, outlining the Quality System Regulation (QSR) for medical devices.
- FDA Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (October 2018), offering guidance for addressing cybersecurity in medical devices.

qointa technologies adeptly gather electronic patient data and electronic patient diary data, both of which satisfy the criteria for ICH-GCP Source Data & Documents.

In accordance with this, all of our solutions are meticulously crafted to adhere to the regulatory rules and guidelines of the US, EU, and other pertinent authorities, encompassing, yet not confined to:

CFR Title 21, a regulatory framework governing food and drugs in the United States, under the oversight of the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP).

21 CFR Part 11, focusing on electronic records and electronic signatures.

PIC/S Guidance, outlining best practices for computerized systems within regulated GXP environments.

EudraLex Rules Governing Medicinal Products in the European Union Volume 4, which includes EU Guidelines to Good Manufacturing Practice and Draft Annex 11 for Computerized Systems.

21 CFR Parts 312, outlining regulations for pharmaceuticals, specifically requirements for new drugs and investigational new drug applications.

21 CFR Part 314, detailing regulations for pharmaceuticals, including requirements for new drugs and applications for FDA approval to market a new drug.

CSUCT (Guidance for Industry: Computerized Systems Used in Clinical Trials).

Clinical Trials Directive 2001/20/EC.

Our commitment to compliance ensures that our solutions meet the highest standards set forth by these regulations and guidelines.