Regulatory and Technical Due Diligence
If you are considering investment in or merger with a medical device firm, Paladin Medical will work with you to conduct due diligence audits. Assessment of the regulatory and quality practices of a medical device company for the purpose of venture capital due diligence or corporate merger requires an understanding of the impact of potential deficiencies on valuation. We can provide comprehensive due diligence assessments of regulatory, design and development and technical documentation from the perspective of future risk. We can help determine whether new medical device firms have sound regulatory and development documentation, meet minimum regulatory requirements, and if there are significant deficiencies that might encumber or may devalue an acquisition. Because due diligence activities are often limited by time and access to internal personnel, we can help you determine where the greatest business and regulatory risks may be and determine a plan of action to evaluate these risk sources. Typical areas where a target company may have deficiencies can include improper product classifications and device listing, inadequate quality system compliance, open corrective actions and audit findings, adverse event reporting and complaint management deficiencies, open recalls, under supported marketing claims, import compliance, and clinical trial management deficiencies, just to name a few. Regulatory and documentation deficiencies can cost significant time and money to correct and represent future liabilities.