Compliance and Regulatory
ForwardBlood is designed from the ground up to operate within the regulatory frameworks that govern blood management in healthcare. Our approach spans FDA quality system requirements, blood banking standards, medical device software lifecycle processes, data security frameworks, and international regulatory bodies.
FDA 21 CFR 820 — Quality System Regulation
ForwardBlood is designed under a quality management system aligned with FDA 21 CFR 820 design controls. Our software development process follows structured design input and design output traceability, ensuring that every requirement is linked to its implementation and verification evidence.
Design reviews are conducted at defined lifecycle stages to evaluate completeness, correctness, and adequacy of design outputs against design inputs. Our verification and validation activities confirm that the software performs as specified under the conditions it will encounter in clinical use.
This quality system alignment is foundational to how ForwardBlood is built — not an afterthought applied to finished software. Design controls, document control procedures, and corrective and preventive action (CAPA) processes are integrated into our daily development workflow.
AABB Standards for Blood Banks and Transfusion Services
ForwardBlood supports workflows aligned with AABB standards for blood product management, donor-to-patient traceability, compatibility testing documentation, and inventory control. The platform is designed to facilitate the operational requirements that blood banks and transfusion services must meet under AABB accreditation programs.
Specifically, ForwardBlood's electronic crossmatch module (ForwardXM) provides auditable compatibility testing records, the inventory module (ForwardStock) maintains real-time unit tracking by type, group, expiration, and location, and the cold chain module (ForwardCold) delivers continuous temperature monitoring with automatic excursion logging — all functions that map directly to AABB operational requirements.
Full chain-of-custody documentation from receipt through transfusion or disposition is maintained automatically, supporting the traceability and record-keeping obligations that AABB standards require of participating facilities.
IEC 62304 — Medical Device Software Lifecycle
ForwardBlood is building to IEC 62304 software lifecycle process requirements. Our development practices are structured around the standard's lifecycle activities: software development planning, requirements analysis, architectural design, detailed design, implementation, integration testing, and system testing.
Requirements management and traceability are maintained throughout the development lifecycle, linking user needs to system requirements, software requirements, and validation tests. Architecture documentation captures the decomposition of the system into software items, with defined interfaces and risk classifications informing the rigor applied at each level.
This is a development process commitment — IEC 62304 defines how we build software, not a product certification. Our maintenance processes, including problem resolution and change control, are designed to sustain lifecycle compliance as the platform evolves.
IEC 82304 — Health Software Product Safety
ForwardBlood is building to IEC 82304-1 health software product safety requirements. Our product safety approach includes hazard identification and analysis specific to blood management workflows, risk estimation and evaluation for each software function, and implementation of risk controls traced to specific requirements.
Risk management is integrated into the development lifecycle rather than conducted as a separate activity. Post-market surveillance planning addresses how field performance data will be monitored and fed back into the risk management process to maintain the safety profile of the software over time.
HIPAA — Health Insurance Portability and Accountability Act
ForwardBlood is pursuing HIPAA compliance across the technical, administrative, and physical safeguard requirements of the Security Rule. Our technical safeguards include encryption of data at rest and in transit, role-based access controls with the principle of least privilege, and comprehensive audit logging of all data access and system events.
Administrative safeguards encompass workforce security awareness training, documented security policies and procedures, information access management controls, and security incident response planning. Physical safeguards are addressed through our cloud infrastructure providers, whose data center security controls are independently audited.
Business associate agreements will be executed with all third-party service providers who may access, transmit, or store protected health information on behalf of ForwardBlood or its customers.
SOC 2 Type II
ForwardBlood is pursuing SOC 2 Type II certification, which evaluates an organization's controls over an extended observation period. Our control environment is being designed to address the trust service criteria for security (logical and physical access controls, network security, change management), availability (uptime monitoring, capacity planning, incident response), and confidentiality (data classification, encryption, secure disposal).
The SOC 2 framework provides independent, third-party assurance to healthcare organizations evaluating ForwardBlood's operational controls. We are building the processes, evidence collection, and continuous monitoring infrastructure required to undergo and sustain a Type II examination.
United Kingdom — MHRA and UKCA
ForwardBlood is designed with UK regulatory requirements in mind, including the Medicines and Healthcare products Regulatory Agency (MHRA) medical device regulations and UKCA marking requirements. Our quality management system and software lifecycle processes are aligned with standards recognized under the UK Medical Devices Regulations 2002 (as amended post-Brexit).
As the UK regulatory landscape for software as a medical device continues to evolve, ForwardBlood monitors guidance from the MHRA and maintains awareness of requirements for device classification, conformity assessment, and post-market surveillance within the UK market.
Canada — Health Canada and CMDR
ForwardBlood is designed with Canadian regulatory requirements in mind, including Health Canada's Medical Devices Regulations (SOR/98-282) and the Canadian Medical Devices Regulations framework. Our approach accounts for device classification, quality system requirements, and the pre-market review process applicable to software as a medical device in Canada.
ForwardBlood's quality management system alignment supports participation in the Medical Device Single Audit Program (MDSAP), which enables a single regulatory audit to satisfy the requirements of multiple regulatory jurisdictions including Canada, the United States, and other participating countries.
Questions About Our Compliance Posture?
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