Our Services
We support MedTech companies at every stage — from early regulatory planning to hands-on quality system implementation and interim leadership roles. Whether you're preparing your first MDR submission or scaling up post-market activities, we offer tailored solutions that drive both compliance and innovation.
Service Areas
Regulatory Affairs
MDR / IVDR strategies
CE-marking for medical devices (incl. Software as Medical Device)
Technical documentation
Notified Body communication
Person Responsible for Regulatory Compliance (PRRC) services
Quality Management Systems
QMS setup (ISO 13485, ISO 14971, ISO 27001)
Internal & external audits
Gap analysis & continuous improvement
Audit preparation & support
Risk management file creation
Leadership & Interim Roles
Interim Quality or Regulatory leadership
QARA team mentoring & coaching
Strategy development
Board & management advisory
Cross-functional project leadership
Get Your Free Tools
Looking for hands-on tools? Download 2 free checklists that help MedTech teams with regulatory readiness and audit prep. Just fill out a short form below.
This resource is available to medtech companies. Please use your corporate email address.
A Proven Process for Compliance Without Complexity
🔍 Step 1: Discovery & Assessment
We start with a discovery meeting to understand your needs, product, and current regulatory or quality status. This helps us assess the scope, risks, and define the right path forward.
🧭 Step 2: Strategy & Roadmap
We create a tailored plan — defining goals, timelines, and deliverables. Whether it’s MDR readiness or QMS implementation, you’ll know what to expect at each step.
⚙️ Step 3: Execution & Support
We work hands-on — not just advise. From documentation and compliance to audits or interim roles, we become part of your team to make real progress happen.
✅ Step 4: Review & Ongoing Support
We evaluate results, hand over key materials, and offer continued support if needed — for scaling, audits, or post-market needs.
Service Packages & Tailored Support
💼 1. Startup Compliance Package
For early-stage MedTech teams preparing for their first regulatory steps.
MDR/IVDR readiness check
Regulatory strategy & CE-marking planning
Light QMS setup (ISO 13485:2016)
Risk management file outline (ISO 14971)
2 advisory sessions/month
🕒 Typical duration: 2–3 months
💡 Ideal for companies developing Software as a Medical Device (SaMD)
📈 2. Scale-Up & Certification Package
For growing MedTech companies preparing for CE-marking or scaling compliance efforts.
Full QMS setup or upgrade (ISO 13485, ISO 27001, ISO 14971)
Technical documentation support
Internal audit & Notified Body prep
PRRC guidance & post-market planning
Ongoing compliance check-ins
🕒 Typical duration: 6–12 months
💡 Includes SaMD and AI system support under MDR & ISO 42001
👔 3. Interim QARA Leadership Package
For companies needing senior, hands-on support inside the team.
Interim Head of Quality or Regulatory Affairs
PRRC as a Service
Internal mentoring & team coaching
Strategic input for board/management
Weekly engagement or fractional role
🕒 Flexible engagement (4–12 months)
💡 Ideal for scale-ups, restructuring, or Notified Body readiness
🧩 Need Something Else?
Tailored Solutions Available
Every company is unique. If your needs don’t fit into a predefined package, we’ll create a custom proposal — from short-term advisory to long-term partnership. Let’s design a solution that works for your product and team.
Executive Leadership & Regulatory Strategy
Support your MedTech business at the executive level with tailored regulatory strategy, leadership, and team development to align compliance with business goals.
Executive Leadership & Regulatory Strategy
Support at the executive level to align product, business, and regulatory priorities.
- Interim or part-time QA/RA leadership
- Align regulatory, business, regulatory with compliance in mind
- Guide strategic decisions with compliance in mind
PRRC (Persion Responsible for Regulatory Compliance)
Official EU MDR-compliant PRRC services tailored to your needs.
- Act as your EU MDR-compliant PRRC.
- Define and implement PRRC processes.
- Interface with authorities and Notified Bodies.
Training & Team Support
Up-skill your team with practical, tailored regulatory and quality training.
Tailored internal QA/RA training
Support onboarding for regulatory and quality roles
Upskill teams in MDR, QMS, and risk management.
Quality Management & Compliance Systems
Build and maintain efficient, ISO 13485-compliant quality management systems and stay audit-ready with our comprehensive compliance and project management services.
Quality Management System (QMS)
Build efficient, ISO 13485-compliant QMS structures that scale with you.
Design and implement ISO 13485-compliant QMS
Deliver complete documentation and SOPs
Support audits and continuous improvement.
Audit & Compliance Reviews
Prepare for and respond to audits with confidence.
Perform internal and supplier audits.
Prepare for Notified Body inspections.
Address CAPAs and resolve deviations.
Project & Change Management
Keep projects moving efficiently while staying compliant.
Lead regulatory and quality projects.
Implement structured change control processes.
Ensure timelines align with compliance goals.
Regulatory & Product Development Support
Navigate the complexities of medical device regulations while embedding quality assurance and validation into your product development lifecycle for smooth compliance.
Regulatory Consulting
Navigate EU MDR, IVDR, AI regulations, and international requirements with confidence.
Prepare and review MDR/IVDR technical files.
Manage CE-marking and Notified Body submissions.
Ensure compliance with ISO 14971, 27001, 62304.
Regulatory Support for Product Development
Ensure regulatory compliance is embedded in your product from day one.
Guidance through the full product lifecycle.
Apply IEC 62304 and 62366-1 during development.
Early alignment with regulatory strategy.
Quality Assurance & Validation Strategy
Enhance product quality and development efficiency with proven QA strategies.
Plan and execute V&V for MedTech software.
Integrate risk-based testing under Agile or hybrid models.
Align QA with ISO 13485, IEC 62304, and MDR.