Mergers & Acquisitions – Comprehensive Due Diligence & Seamless Integration

Expanding your medical device portfolio through acquisitions requires strategic planning, regulatory expertise, and quality compliance diligence. Whether you are acquiring a medical device company or purchasing a product to strengthen your existing market position, your organization inherits all regulatory, compliance, and liability risks associated with that acquisition. A lack of proper due diligence can lead to unforeseen challenges such as product recalls, costly redesigns, legal claims, or compliance violations.

At Realistic Quality Solutions (RQS), we help companies navigate the complexities of mergers and acquisitions, providing deep regulatory insights, risk mitigation strategies, and post-acquisition integration support to ensure long-term success.

Strategic Acquisition Due Diligence – Identifying & Mitigating Risks

Before completing an acquisition, RQS conducts a comprehensive regulatory and quality assessment to uncover potential risks and ensure compliance alignment.

1. Regulatory Compliance & Quality System Evaluation
2. Product Labeling, Branding & Marketing Compliance Review
3. Submissions, Registrations & Market Approval Analysis
4. Product History, Recalls & Adverse Event Reporting
5. Legal Liability & Risk Assessment

Post-Acquisition Integration & Compliance Management

Once an acquisition is completed, RQS provides structured integration plans to ensure a smooth transition, aligning regulatory systems, operational procedures, and market strategies.

1. Integration Planning & Regulatory Transition Strategy
2. Manufacturing Site Transfer & Regulatory Filings Update
3. MDSAP Audit Preparation & Post-Merger Compliance Alignment
4. Risk Mitigation & Regulatory Harmonization
5. Ongoing Compliance Monitoring & Long-Term Regulatory Strategy