You can open the Medical Device Quality Agreement Template in multiple formats, including PDF, Word, and Google Docs.
Medical Device Quality Agreement Template Printable | Editable FormSample
[Name of the Manufacturer]
[Manufacturer’s ID]
[Manufacturer’s Address]
[Manufacturer’s Phone]
[Manufacturer’s Email]
[Name of the Supplier]
[Supplier’s ID]
[Supplier’s Address]
This Quality Agreement outlines the responsibilities and obligations of both parties to ensure compliance with regulatory requirements for medical devices, effective from [Contract Start Date].
This agreement applies to the following medical devices: [List specific devices]. Both parties agree to adhere to quality standards as defined by [Relevant Regulations/Standards].
The Manufacturer shall ensure:
The Supplier shall provide:
All products delivered under this agreement must meet the following specifications: [Specify technical specifications and requirements].
Changes to product design or manufacturing processes must be communicated and approved in writing by both parties prior to implementation.
Both parties shall comply with applicable local and international regulations governing the manufacture, distribution, and sale of medical devices.
Both parties agree to keep all sensitive information confidential and shall not disclose it to any third party without prior written consent.
This agreement shall be governed by the laws of [Jurisdiction].
[Signature of the Manufacturer]
[Name of the Manufacturer]
[Signature of the Supplier]
[Name of the Supplier]
[Name of the Manufacturer]
[Manufacturer’s ID]
[Manufacturer’s Address]
[Manufacturer’s Phone]
[Manufacturer’s Email]
[Name of the Supplier]
[Supplier’s ID]
[Supplier’s Address]
This agreement defines the quality standards and responsibilities between the Manufacturer and Supplier for medical device products, effective from [Contract Start Date].
The parties agree that the products to which this agreement applies are as follows: [List specific medical devices].
The Manufacturer shall maintain a Quality Management System in accordance with [ISO 13485/Other Applicable Standards]. The Supplier must ensure all materials supplied meet agreed quality requirements.
In the event of a non-conformance, both parties must follow the agreed procedures for product evaluation, reporting, and corrective actions.
Both parties commit to providing appropriate training to their personnel involved in quality assurance and compliance.
Regular reviews and quality audits will be conducted annually or as required to ensure compliance with this agreement.
Both parties agree to indemnify and hold harmless the other party from any claims arising from non-compliance with this agreement.
This agreement may be terminated under the following conditions: [Specify conditions].
[Signature of the Manufacturer]
[Name of the Manufacturer]
[Signature of the Supplier]
[Name of the Supplier]
Form
Please complete the form below to create the Medical Device Quality Agreement Template. All fields must be filled out to ensure a clear and complete agreement. We provide examples to guide you through each step. Medical Device Quality Agreement Template 1. Manufacturer Information 2. Client Information 3. Agreement Overview 4. Product Description 5. Quality Management System Requirements 6. Responsibilities and Roles 7. Quality Control Procedures 8. Non-conformance Management 9. Confidentiality Terms 10. Termination Conditions 11. Signatures and Acceptance 12. Declaration and Signatures
PDF
WORD
Medical Device Quality Agreement Template Printable | Editable FormPrintable
