Services

Identify and fix what’s broken before regulators do.

We help medical device companies address gaps in design controls, technical documentation, risk management, verification and validation, traceability and more—without unnecessarily rebuilding years of development work. We do whatever is needed to close the gaps.

We help with:

• DHF remediation
• Design control gaps, including design inputs, outputs, and traceability
• Risk management and FMEA
• Supplemental testing and technical justification
• Legacy product compliance
• Regulatory documentation and deficiency responses FDA, EU MDR, MDSAP, NMPA, PMDA & more

We support medical device teams throughout product development, helping establish design controls, define product requirements, develop risk management strategies, and build the technical documentation and objective evidence needed to satisfy regulators.

When submission deadlines are approaching, we work across R&D, Quality, and Regulatory to turn requirements into actionable deliverables and get critical work across the finish line.

We support:

• New Product development
• Product requirements & design inputs
• Risk management & FMEA
• Verification, validation & test methods
• Technical documentation & DHF
• Preclinical & clinical engineering
• Regulatory submissions & deficiency responses
• Global regulatory strategy and execution— FDA, EU MDR, MDSAP, NMPA, PMDA & more

Integrate acquired products without inheriting their problems.

Acquiring a medical device often means inheriting years of technical documentation, design decisions, manufacturing processes, and compliance history. We help organizations assess, remediate, and transfer acquired products into the acquiring company’s design controls and quality system.

We bridge the gap between the purchased product and the new organization —determining what can be transferred, what needs to be remediated, and what additional evidence is required for regulatory compliance.

We support:

• PRE-Acquisition due diligence and technical assessments
• POST-Acquisition DHF and technical documentation transfer
• Design control integration
• QMS integration
• Manufacturing and process transfer
• Product DHF Gap assessment and remediation planning
• Global regulatory continuity

Know before your buy

A medical device acquisition can carry technical and regulatory liabilities that aren’t obvious from financial or commercial due diligence.

We assess the product from an engineering, design-control, verification and validation, manufacturing, and regulatory perspective—identifying problems that could affect the value or transferability of the acquisition.

We look beyond whether documentation exists. We assess whether the underlying product, development evidence, testing, manufacturing processes, and technical infrastructure can support the acquiring organization’s requirements.

Our assessments can identify:

• Missing or inadequate design documentation
• DHF / DDF gaps
• Design-control deficiencies
• Manufacturing processes that may not be transferable
• Specialized or obsolete equipment dependencies
• Supplier and process dependencies
• Technical remediation requirements
• Potential post-acquisition capital and development requirements

The objective is straightforward: Understand the technical reality before the transaction closes.