Services
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
We implement digital quality management systems tailored to your needs, fully aligned with ISO 13485, FDA 21 CFR 820, MDR/IVDR, and MDSAP. The result is a scalable, audit- and inspection-ready system that supports seamless documentation, traceability, and continuous compliance.
Auditing
Beyond compliance checks, we conduct internal audits, supplier qualifications, and supplier performance audits that uncover risks, strengthen your supply chain, and prepare you for regulatory inspections.
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
Define the regulatory pathway by determining the product’s risk class, mapping global requirements, and building a compliance roadmap that minimizes delays and maximizes market potential.
Submissions
Prepare and compile technical documentation for global approvals, including US (510(k), De Novo, PMA), EU (CE marking), Health Canada, Brazil, Japan, and more, ensuring dossiers are complete and regulator-ready.
Documentation
Develop and maintain compliant labeling, UDI systems, and post-market surveillance (PMS) plans that meet regulatory requirements, supporting traceability and lifecycle compliance.
Clinical Evidence
Design and author Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-Up (PMCF) plans, ensuring your evidence package withstands the increasing scrutiny of EU MDR/IVDR and global regulations.
Authority Interaction
Act as your partner in regulatory communication, guiding responses during authority and notified body reviews, managing inquiries, and facilitating smooth approval processes.
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
End-to-end guidance for product development, coordinating cross-functional teams from concept through design, verification, validation, and market launch.
Biocompatibility
Comprehensive ISO 10993 biological safety assessments and plan, ensuring your medical devices meet global safety standards and regulatory expectations.
Risk Management
Implement ISO 14971-compliant risk management, including hazard identification, risk analysis, evaluation, and mitigation strategies to ensure device safety and regulatory compliance.
Usability & Human Factors Engineering
Execute IEC 62366 usability studies, including formative and summative evaluations, ensuring devices are safe, effective, and user-friendly.
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
Evaluate QMS, certifications, and regulatory filings.
Product Readiness
Assess clinical, technical, and regulatory maturity.
Gap Analysis
Identify compliance gaps, potential risks, projected timelines, and cost-to-compliance estimates, providing a clear roadmap.
Investment Insights
Deliver actionable recommendations and risk-reduction strategies to support informed investment decisions and highlight growth opportunities.
Swiss Authorized Representative (CH-Rep)
Switzerland is a leading hub for medtech innovation. As your Swiss Authorized Representative (CH-Rep), we ensure your products fully comply with MDR/IVDR requirements, manage ongoing post-market surveillance and vigilance obligations, and facilitate seamless market access, minimizing regulatory risk and enabling smooth operations in the Swiss market.
Representation
Establish CH-Rep agreement.
Verification
Review product technical documentation, labeling, and declarations to ensure full compliance with MDR/IVDR requirements.
Swissmedic Liaison
Serve as your regulatory interface, managing communications and interactions with authorities to streamline approvals and compliance processes.
Monitoring
Support ongoing PMS, vigilance, and compliance updates.