Services · Investment & M&A

MedTech Investment &
Acquisition Due Diligence

Smart investors know that many startups overstate their position during the investment or acquisition process. We help you cut through the noise and understand the real risk.

The Challenge

Know what you're buying
before you commit.

Many startups overstate their regulatory and quality position during the investment or acquisition process to maximise their perceived value. The consequences for investors can be significant — delayed timelines, costly remediation, or regulatory rejection of the product entirely.

XioMed provides independent, expert due diligence to give investors and acquirers a clear, honest picture of where a target company actually stands — across its quality management system, regulatory compliance, technical documentation, and readiness to scale.

Book a Free Consultation

Our Process

  1. 1
    Free Initial Consultation Discuss your requirements, the target company, and the level of due diligence needed.
  2. 2
    Custom Due Diligence Plan We create a tailored scope of activities proportionate to your investment and risk profile.
  3. 3
    Expert Assessment An appointed specialist conducts due diligence activities on the target company.
  4. 4
    Detailed Report A comprehensive report captures findings, risk exposure, and clear recommendations.

What We Cover

Example Due Diligence Activities

Every engagement is scoped to your specific needs. The following are typical activities conducted during a MedTech due diligence review.

Quality Management

QMS Review

Assessment of the Quality Management System to determine its suitability, maturity, and the organisation's actual level of compliance.

  • ISO 13485 compliance assessment
  • QMS documentation review
  • Non-conformance & CAPA records
  • Management review evidence
Regulatory Compliance

Technical Documentation

Review of technical files and regulatory submissions to determine the product's true compliance status and identify any gaps.

  • Technical file completeness
  • EU MDR / IVDR compliance
  • Risk management files (ISO 14971)
  • Clinical evaluation reports
Audit History

Audit Records

Review of internal and third-party audit records to understand the organisation's compliance track record and identify recurring issues.

  • Internal audit programme & records
  • Notified body audit findings
  • Supplier audit records
  • Corrective action closure rates
Product Development

Development Activities

Assessment of the product development programme to evaluate the realistic timeline to market and identify technical risks.

  • Design history file review
  • V&V status and completeness
  • Timeline to CE mark / FDA clearance
  • Outstanding technical risks
Operations

Manufacturing & Supply Chain

Review of manufacturing processes and supply chain to identify operational risks and assess readiness to scale production.

  • Manufacturing process maturity
  • Supplier qualification status
  • Single-source component risks
  • Scale-up readiness assessment
Commercial Readiness

Portfolio Review

For portfolio-level assessments, we provide a landscape review of regulatory requirements and compliance maturity across multiple assets.

  • Multi-product regulatory mapping
  • Comparative risk profiling
  • Remediation cost modelling
  • Prioritisation recommendations

Considering a MedTech investment
or acquisition?

Talk to us before you commit. We'll give you an honest, independent assessment of the target company's regulatory and quality position.

Book a Free Consultation