INTERNATIONAL MEDICAL DEVICE REGULATORY AFFAIRS

Your Medical Devices. Every Market. Practically Perfect.

I help MedTech manufacturers navigate international market approvals for Class I to IIb medical devices across 80+ countries — so you can focus on innovation whilst I handle the regulatory complexity.

80+

Countries Covered

12+

Years in MedTech

I-IIb

Medical Device Risk Classes

SOUND FAMILIAR?

International Approvals Shouldn't Keep You Up at Night

Expanding into new markets is essential for growth — but regulatory hurdles can stall even the most promising devices. Here's what I hear from MedTech teams every week.

Overwhelmed by Market Requirements

Every country has unique regulatory frameworks. Navigating 80+ different sets of requirements without specialist knowledge leads to costly mistakes and delays.

MDSAP Audit Anxiety

Preparing for MDSAP audits whilst maintaining day-to-day operations stretches teams thin. Documentation gaps only surface when it's too late.

Team Capacity Stretched

Your regulatory affairs team is brilliant — but they can't be experts in every market. International registrations demand specialist knowledge that's hard to hire for.

Approval timelines Slipping

Every country has unique regulatory frameworks. Navigating 80+ different sets of requirements without specialist knowledge leads to costly mistakes and delays.

Change Notifications Piling Up

Keeping registrations current across dozens of markets means constant change notifications and re-registrations, each with its own timeline and requirements.

Regulatory Intelligence Gaps

Requirements change constantly. Without systematic monitoring, you risk non-compliance, market suspension, or missed opportunities in emerging markets.

WHAT I DO

Comprehensive Regulatory Support, Tailored to Your Needs

From strategic planning to hands-on submission management I cover the full spectrum of international regulatory affairs.

Strategic Regulatory Consultancy

Market registration strategies, regulatory roadmaps, and project management for international approvals.

  • Market registration strategy development

  • Regulatory requirements analysis

  • Regulatory roadmap planning

  • Approval project management

Quality Management & MDSAP

MDSAP-compliant documentation systems and audit preparation aligned with P0002.009, Chapter 2.

  • MDSAP audit-ready documentation

  • MDSAP compliance support

  • SOP & work instruction development

  • Process optimisation

Product Owner & Management

Product ownership and development for regulatory software tools — from SaaS platforms to standalone solutions.

  • Product Owner for software development

  • Product lifecycle management

  • Prototyping & UX (Figma)

  • Software implementation & optimisation

International Registrations

End-to-end management of medical device registrations for Classes I–IIb across all international markets.

  • Regulatory affairs management

  • Change notification processing

  • Re-registration management

  • Submission dossier preparation

Research & Monitoring

Stay ahead of regulatory changes with systematic surveillance and impact analysis across your markets.

  • Regulatory requirement monitoring

  • Impact analysis of changes

  • Market-specific requirement updates

Project & Team Leadership

Agile project management, cross-functional team coordination, and interim team lead support.

  • Agile methods (Kanban, Scrum)

  • Stakeholder management & reporting

  • Team development & training

  • KPI definition & resource planning

WHY WORK WITH ME

The Right Expertise at

the Right Time

I'm Annika Lörtscher — a regulatory affairs consultant who's spent over 12 years helping MedTech manufacturers get their devices to market internationally. I've managed registrations in 80+ countries and built the systems, strategies, and teams to keep them compliant.

Deep Specialist Knowledge

Proven expertise in complex markets including Brazil, China, South Korea, Russia, and Saudi Arabia, the markets where general knowledge isn't enough.

Strategic & Practical

I don't just advise, I implement. From developing regulatory strategies to preparing submission dossiers, I deliver end-to-end.

Flexible Partnership

Monthly pools, annual retainers, or project-based support — choose the engagement model that fits your needs and budget.

Multilingual & Cross-Cultural

Native German, C1 English, B1 French. Based in Switzerland, available remotely and on-site worldwide.