M&A Due Diligence & Integration

Navigate Complex Mergers with Confidence and Precision

Key Challenges We Address:

In the dynamic landscape of medical technology mergers and acquisitions, aligning regulatory strategies is paramount to unlocking full deal value.

Regulatory Risk Exposure:

Identifying and mitigating compliance gaps that could jeopardize deal value.

Quality Management System (QMS) Disparities:

Aligning differing QMS frameworks to prevent operational bottlenecks.

Time-to-Market Delays:

Streamlining regulatory pathways to expedite product launches post-merger.

Our Comprehensive Service Offerings

Pre-Acquisition Technical Due Diligence

Thorough evaluation of target entities to uncover potential regulatory and technical liabilities.

Deliverables:

Technical Documentation Audits: In-depth reviews of Design Dossiers and Technical Files for compliance with MDR, IVDR, and FDA 21 CFR Part 820.
Risk Assessment Reports: Identification of product and process risks in line with ISO 14971 standards.
Regulatory Pathway Mapping: Strategic guidance on approval processes across key markets, including EU and US jurisdictions.

Compliance Roadmap Tailored to Device-Specific Requirements

Creating a compliance roadmap tailored to your medical device’s unique requirements is crucial for regulatory success.

Our customized roadmaps outline essential steps and milestones for achieving regulatory approval.

Our approach ensures a clear, actionable path to compliance, helping you avoid delays and meet all regulatory expectations.

Services:

Technical M&A Advisory

Thorough evaluation of target entities to uncover potential regulatory and technical liabilities.

Deliverables:

QMS Compatibility Analysis: Evaluation of existing Quality Management Systems against ISO 13485 to identify integration challenges.
Design Dossier Evaluations: Critical assessment of product design documentation for compliance and innovation potential.
Integration Risk Identification: Flagging of potential technical and regulatory hurdles that could impede merger objectives.

Post-Merger Integration and Regulatory Harmonization

Structured support to unify regulatory frameworks and quality systems, ensuring sustained compliance and operational efficiency.

Services:

QMS Harmonization Plans: Development and implementation of unified Quality Management Systems adhering to ISO 13485 and FDA QSR.
Technical Documentation Remediation: Updating and aligning Technical Files to meet MDR and IVDR requirements.
Compliance Infrastructure Development: Establishment of robust processes for ongoing adherence to global regulatory standards.

Expertise in Global Regulatory Frameworks

Our team possesses deep proficiency across international standards and regulations, including:

European Union:
Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR)

United States:
FDA 21 CFR Part 820 (Quality System Regulation)

International Standards:
ISO 13485 (Quality Management Systems), ISO 14971 (Risk Management for Medical Devices)

Why Partner with Us?

Proven Track Record:
A history of successful collaborations with leading MedTech firms, delivering measurable M&A success.

Global Reach:
Extensive experience navigating regulatory environments across major international markets.

Risk Mitigation Focus:
Dedicated to identifying and addressing compliance risks to protect and enhance deal value.

Accelerated Compliance:
Strategies designed to streamline regulatory approvals, reducing time-to-market for your products.

Let's Talk Integration

Embark on your M&A journey with a partner that understands the intricacies of MedTech regulatory landscapes. Contact us to explore how our expertise can facilitate a seamless, compliant, and value-driven integration.

Swiss MPC GmbH Riedmatt 2, 6300 Zug, Switzerland