About us
Specialized expertise in Quality Assurance and Regulatory Affairs delivers comprehensive support for the medical device, SaMD, and MedTech industries.
With a proven track record of collaborating with leading international notified bodies, global technology consulting firms, and manufacturing enterprises, navigating the complex landscapes of MDR, IVDR, ISO 13485, and Cybersecurity is handled with absolute precision.
The core mission is to bridge the gap between innovative software development and strict legal compliance, ensuring that medical systems reach international markets swiftly, safely, and in full alignment with top-tier international standards.
A few things we’re great at
Proven Competence in Medical Compliance
Unrivaled industry insight and extensive field experience ensure that quality systems, information security, and technical documentation meet the rigorous expectations of international regulatory authorities
Notified Body & Auditing Expertise
Years of firsthand experience executing and managing medical device audits for leading international certification bodies (including BSI and TÜV Rheinland) provide a deep, practical understanding of auditor expectations and regulatory conformity evaluations
Active Medical Devices & SaMD Specialization
Comprehensive technical proficiency covers active medical technologies across risk classes, spanning specialized hardware to high-tech software solutions, including Software as a Medical Device.
Integrated QMS & Cybersecurity Implementation
Demonstrated success in establishing, supervising, and optimizing integrated management environments that simultaneously satisfy both Quality Management (ISO 13485 / ISO 9001) and Cybersecurity criteria.
Get started
Initiating a project is a structured, transparent process designed to integrate seamlessly into existing operations, whether dealing with a startup or an established enterprise:
- Initial Assessment & Discovery: A preliminary consultation clarifies the specific regulatory scope, device classification, or quality system requirements.
- Gap Analysis & Strategy Mapping: Current technical documentation, product validation state, or existing QMS frameworks are analyzed to establish a clear project roadmap.
- Actionable Proposal: A detailed scope of work is presented, outlining clear milestones, regulatory responsibilities, and timelines tailored to the strategic goals.
- Kick-Off & Integration: Project execution begins with direct alignment on communication channels, risk management processes, and target evaluation objectives.
Measure your progress
Project progress is tracked through complete visibility and measurable milestones at every stage of execution, aligned with your project management methodology:
- Milestone Reporting & Deliverables: Transparent documentation and comprehensive reports are delivered upon the completion of key phases, such as finished gap analyses, QMS document drafts, or software validation protocols.
- Status Reviews & Alignment: Regular, scheduled briefing sessions keep stakeholders aligned on upcoming validation deadlines, non-conformity evaluations, and regulatory submissions.
- Risk & Compliance Log: Critical paths, potential compliance risks, and corrective/preventive action items are continuously logged and communicated to prevent project delays.
Services
Notified Body Audits & Audit Preparation
Comprehensive support throughout the entire auditing cycle
Services include conducting pre-assessments, performing internal mock audits, identifying gaps, and providing hands-on representation during formal audits by major Notified Bodies for ISO 13485 and MDR compliance.
Fractional Regulatory Manager
On-demand access to high-level Quality and Regulatory Affairs management expertise. This service delivers strategic guidance, QMS maintenance, stakeholder requirement communication, and compliance oversight without the long-term overhead of a full-time executive hire.
Class-to-Class Remediation Projects
Expert technical and strategic assistance when transitioning medical devices between risk classes, or moving from legacy directives to current regulations (MDD to MDR). Legacy data, technical files, and product conformity documentation are fully upgraded to fulfill new legal standards.
MedTech Support for Venture Capitals
In-depth technical and regulatory due diligence for investment firms, venture capital, and tech consulting pipeline. This service mitigates investment risks by evaluating target companies’ technical documentation, software validation state, and overall path to market viability.
Cybersecurity for Medical Devices
Securing connected medical technologies through robust risk management. This involves defining, supervising, and implementing Cybersecurity that aligns with software data security, privacy requirements, and active device regulatory standards.
Regulatory Project Management
End-to-end execution of complex MedTech initiatives. Acting as the central coordinator, this service manages software development lifecycles (SDLC), coordinates cross-functional validation activities, and oversees software and process validations required for regulatory approval.
What are you waiting for?
Professional support in Quality Assurance, Regulatory Affairs, and Information Security is available to help streamline the certification pathway for medical technologies. Partner with an experienced industry expert to ensure seamless compliance with MDR, IVDR, and international standards.
Reach out to discuss project-specific requirements, gap analyses, or audit preparation needs