Our services encompass all categories of medical software, including Software in a Medical Device (SiMD), Software as a Medical Device (SaMD), mobile medical apps (MMA), and accessory software for active medical devices.

We ensure strict adherence to IEC 62304:2006+AMD1:2015 while seamlessly integrating requirements from ISO 14971 (Risk Management), IEC 62366 (Usability), and global cybersecurity guidelines (FDA/MDR). We bridge the gap between agile R&D and rigid regulatory requirements, helping manufacturers mitigate cybersecurity risks and reduce the cost of multi-market global entry.

1.2 Core Service Advantages

Global Regulatory Authority: Our ISO 17025accredited laboratory provides cybersecurity testing and compliance reports recognized by regulators in over 140 countries.
End-to-End Closed-Loop Lifecycle: From pre-R&D planning to post-market maintenance, we provide a unified quality system that adapts to the entire product life.
Customized Risk-Based Solutions: Tailored compliance frameworks for Class A, B, and Csoftware, balancing agile development efficiency with the traceability demands of global standards.
Technical & Regulatory Dual Empowerment: Beyond documentation, we provide hands-on technical support, including secure coding guidance, penetration testing, and vulnerability management (VMS).

1.3 Standardized Service Process

Stage	Core Service Highlights
I. Gap Analysis	Product risk classification; full-dimensional assessment of existing R&D processes against IEC 62304 and target market mandates; actionable rectification roadmap.
II. Compliance Strategy	Phased implementation plans defined by software risk level (A/B/C) and target markets (NMPA/FDA/CE), with clear deliverables and timelines.
III. QMS & Development Guidance	Establishing configuration management and change control; implementing secure coding, data encryption, and access control protocols.
IV. Verification & Validation (V&V)	IEC 62304-compliant testing; functional/performance verification; Cybersecurity Penetration Testing; issuing CNAS/CMA accredited reports.
V. Technical Documentation	Authoring and reviewing the full suite: SDP, SRS, SDS, RMF, and PMS procedures to ensure 100% audit readiness.
VI. Global Registration Support	Direct interfacing with FDA, EU Notified Bodies, and NMPA; responding to technical inquiries and accelerating market clearance.

1.4 Full-Scenario Solutions

Agile-to-Compliance Adaptation: Synchronizing "Agile Iteration" with "Full-Link Traceability" to maintain R&D velocity without sacrificing regulatory rigor.
Cybersecurity Specialized Compliance: Deep-dive services covering vulnerability monitoring, encryption, and threat modeling to meet evolving FDA/MDR cybersecurity expectations.
Global Synchronous Entry: A "Test Once, Apply Everywhere" approach for NMPA, FDA, EU MDR, TGA, and Health Canada to minimize redundant costs.
Audit Rectification & Rescue: Rapid system optimization and document remediation for non-conformities found during NB audits or regulatory inspections.

START YOUR PROJECT TODAY

Send Us an Email

Services: Software Lifecycle & Cybersecurity; Usability & Human Factors Engineering; Medical Device MRI Compatibility Testing; IEC 62304

LATES NEWS: Don't miss our news subscription, please fill in the form below.

Contact Us: Room 2056, Zone B, 2nd Floor, Building 3, 516 Huncun Road, Baoshan District, Shanghai; info@ebitmed.com

Follow Us