A Medical Equipment Lease & Purchase Agreement governs acquisition or leasing of medical devices and technology. This playbook addresses maintenance, warranties, and ownership transfer terms.
Why This Matters: Protects patient safety, compliance with regulators, and reduces the risk of recalls, liability, and reputational damage.
Negotiation strategy
If you're the Healthcare Provider:
Insist on detailed quality metrics and testing protocols. Ensure corrective actions are clearly defined for non-conforming deliverables.
If you're the Lessee:
Propose adherence to industry standards while allowing flexibility in corrective actions. Highlight existing compliance with regulatory bodies.
Essential elements
1
Quality Metrics
Specific standards to be met.
2
Testing Protocols
Procedures for product testing.
3
Corrective Actions
Steps for non-conformance.
Action framework
ACCEPT
Propose edits if metrics or protocols are vague.
EDIT
Reject if no clear corrective actions are included.
ADD
Add if clause lacks regulatory compliance language.
PRO TIP
Always align quality standards with the latest regulatory requirements to avoid compliance issues.
Example clauses
FAVORABLE
Preferred Clause
"The Supplier shall ensure all products meet the following quality metrics: [insert metrics]. Testing protocols shall be conducted in accordance with [insert protocols]. Corrective actions for non-conforming deliverables shall include [insert actions]."
NEUTRAL
Fallback Clause
"The Supplier shall adhere to industry-standard quality and safety protocols, including testing and corrective actions for non-conforming deliverables."
UNFAVORABLE
Unfavorable Clause
"The Supplier shall make reasonable efforts to meet quality standards."
Fallbacks
High-Risk Projects
In high-risk projects, ensure more stringent quality metrics and frequent testing protocols to mitigate potential risks.
International Compliance
For international projects, include compliance with global regulatory standards to ensure market access.
New Product Launch
For new products, establish robust testing protocols and rapid corrective actions to address unforeseen issues.
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