SmartPath AG

Whether you are in the investment phase, actively developing a medical device, or seeking to position an existing device differently in the market, we provide comprehensive services for medical device development and life cycle management.

• Process-driven expertise across a wide range of medical applications (e.g. cardiovascular, orthopedics, dental, wound management, and regenerative medicine).
• Problem-solving experience in development, manufacturing, and regulatory compliance.
• Flexible support providing hands-on expertise to coverspecific project functions when resources are limited.
• Investor insights delivering due diligence and rescue strategies to protect your investments.

Quality Management

A robust Quality Management System (QMS) is the foundation of regulatory compliance and market readiness. We help medical device companies implement and customize eQMS solutions aligned with ISO 13485, FDA 21 CFR 820, MDR/IVDR, and MDSAP. Our approach transforms quality from a compliance obligation into a strategic advantage.

• eQMS implementation
• Auditing

Regulatory & Clinical Affairs

We guide our customers in defining regulatory and development strategies that accelerate time-to-market, ensure compliance and reduce costs. By combining global submission expertise, product risk classification, and robust clinical evidence, we help turn complex regulatory pathways into a business strategic leverage.

• Smart strategy for faster, compliant market access
• Submissions
• Documentation
• Clinical Evidence
• Authority Interactions

Product Development

From concept to commercialization, compliance and patient safety must be embedded in every stage of product development. We integrate biocompatibility (ISO 10993), usability engineering (IEC 62366), risk management (ISO 14971) into your processes. This ensures safe, effective, and user-centered devices that meet regulatory requirements and accelerate time-to-market.

• Project Management
• Biocompatibility
• Risk Management
• Usability & Human Factors Engineering

Due Diligence for Investors

Investing in medical devices carries regulatory, clinical, and technical risks. Our due diligence assessments provide a reality check of QMS maturity, regulatory compliance, product readiness, and risk exposure, empowering investors with the data-driven insights needed to make confident investment decisions and reduce market entry uncertainty.

• Regulatory Review
• Product Readiness
• Gap Analysis

Due Diligence for Investors

Investing in medical devices carries regulatory, clinical, and technical risks. Our due diligence assessments provide a reality check of QMS maturity, regulatory compliance, product readiness, and risk exposure, empowering investors with the data-driven insights needed to make confident investment decisions and reduce market entry uncertainty.

• Representation
• Verification
• Swissmedic Liason
• Monitoring