Our operations are built on a comprehensive understanding and strict adherence to globally recognized standards, ensuring the highest levels of quality, security, and compliance:

• ISO 13485:2016: This standard sets the benchmark for quality management systems in the medical device industry, ensuring products consistently meet customer and regulatory requirements.

• ISO 9001: A foundational quality management standard that guides consistent, customer-focused performance across various industries.

• ISO 27001:2017: A framework dedicated to establishing, implementing, maintaining, and continually improving an Information Security Management System (ISMS), safeguarding sensitive information.

• IEC 62304: This standard is critical for compliance with Medical Device Software Lifecycle Processes, ensuring that software used in medical devices is safe and reliable.

• FDA 21 CFR Part 11: This regulation outlines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records, ensuring compliance within regulated environments.

• EU Annex 11: A key guideline governing computerized systems used in the manufacture of pharmaceuticals, ensuring these systems meet strict regulatory requirements.

These standards collectively reinforce our commitment to maintaining excellence in all facets of our operations, from product development to data security. 

qointa’s solutions are meticulously crafted to align with leading industry guidelines and regulations, ensuring robust data protection and confidentiality:

• Directive 95/46/EC: A foundational regulation that safeguards the processing of personal data and its free movement within the EU.

• COMMISSION DECISION 2002/16/EC: Establishes standard contractual clauses for the secure transfer of personal data to processors in third countries, supporting compliance with Directive 95/46/EC.

• Directive 2002/58/EC: Addresses data protection and privacy in electronic communications, building on the principles established in Directive 95/46/EC.

• 45 CFR Parts 160/164: Encompasses the HHS Standards for Privacy of Individually Identifiable Health Information and the Security Standards for Electronic Protected Health Information, as mandated by HIPAA regulations.

• BC 5701 (GDPR): This regulation establishes comprehensive data protection standards, ensuring that personal data is processed securely and with respect to individuals’ privacy rights.

By rigorously adhering to these standards, Qointa ensures the highest level of data protection and privacy across all our solutions, from patient confidentiality to secure data access.

qointa is well-versed in a comprehensive array of regulatory frameworks, ensuring compliance with critical industry regulations:

• MDR (Medical Devices Regulation): Governs the safety and performance of medical devices within the EU.

• IVDR (In Vitro Diagnostic Medical Devices Regulation): Regulates the market entry and performance of in vitro diagnostic medical devices within the EU.

• FDA 21 CFR Part 820: Outlines the Quality System Regulation (QSR) for medical devices, ensuring that devices are safe and effective.

• FDA Guidance on Cybersecurity in Medical Devices: Provides best practices for managing cybersecurity risks in medical devices, essential for protecting patient safety and data integrity.

These regulatory frameworks are integral to our operations, ensuring that our products and services meet the highest standards of safety, quality, and compliance.

qointa’s technologies are designed to capture and manage electronic patient data with strict adherence to global clinical research regulations:

• 21 CFR Parts 312 and 314: Outline the regulatory requirements for pharmaceuticals, covering investigational new drug applications and the approval process for new drugs in the US.

• CSUCT: Guidance for the use of computerized systems in clinical trials, ensuring that these systems meet regulatory requirements.

• 21 CFR Part 11: Ensures that electronic records and signatures in clinical trials are trustworthy and reliable, meeting the stringent requirements of the FDA.

• PIC/S Guidance: Provides best practices for the use of computerized systems in regulated GXP environments, ensuring data integrity and compliance.

• EudraLex Volume 4: Encompasses the EU Guidelines to Good Manufacturing Practice and Annex 11 for computerized systems, ensuring compliance within the pharmaceutical industry.

• Clinical Trials Directive 2001/20/EC: Governs the conduct of clinical trials in the EU, ensuring the protection of trial participants and the credibility of clinical trial data.

We support the generation and submission of real-world evidence (RWE) including observational studies, registry data and digital health outputs to support regulatory and reimbursement strategies

qointa’s commitment to regulatory compliance ensures that our solutions not only meet but exceed the stringent requirements of these global standards.