Medical Device Due Diligence Report Template

D

DesiQE

#1
We may be looking at acquiring a company. What are the main requirements of a due diligence as related to a medical device company? Would any of you have templates you could share with me, for checklists (technical, QA, RA) and for the final report?

Your speedy help is requested and will be highly appreciated.
 
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Stijloor

Staff member
Super Moderator
#2
We may be looking at acquiring a company. What are the main requirements of a due diligence as related to a medical device company? Would any of you have templates you could share with me, for checklists (technical, QA, RA) and for the final report?

Your speedy help is requested and will be highly appreciated.
Can someone with this type of experience help?

Thank you very much.

Stijloor.
 

Michael Malis

Quite Involved in Discussions
#3
Due Diligence Analysis are essential tools for reducing the risk for potential buyer of medical device companies.

This type of audit emphasize Financial, Business, Research Compliance, Regulatory and Quality Managements Systems risks. Today, Medical Device company operates in heavily regulated Global environments. The ability of a company to meet those requirements often is the determining factor in a company’s viability and profitability. Or subjected your company to significant regulatory exposure.

There are a number of certified, competent Lead Auditors are available in your field. They will have the most effective and cost-efficient due diligence & GAP analysis processes and many years of experience.

It is my advice for you to contact some of those companies and get the right skill set required to conduct a successful regulatory due diligence. They also will provide the paperwork necessary to conduct a thorough and reliable appraisal.

Without this how do you really know the Real state of Research Compliance for your target company?
Do you know if study in progress has been reviewed and accepted by the appropriate bodies?
Any issues arising from the conduct of the study and study subjects?
Are there any problems with the validity of the data collected?
Have there been reports of Adverse Events?
Will the study be completed on time?

From Regulatory point of view - what is the status of Device approvals?,
Licenses and certifications?
Does your Target have an appropriate Quality Management Systems in place? What is the functionality of the QMS?
What are the results of regulatory and QMS audits by outside authorities? Results of Internal audits? Are all products and processes properly validated? Software validations?
What is the Status of Subcontractors and suppliers, and related agreements? Review of complaints and adverse events?
Any recalls or alerts, advisory notices, etc? Status of CAPA’s and their effectiveness?

The due diligence audit also should include distribution activities.
What is the status of the target company and its devices in the world market? What is the likelihood of obtaining regulatory approval in key foreign markets? Any compliance issues which might hinder a proposed distribution agreement?

If you as a buyer will need to correct any of these regulatory problems, this will help to adjust the purchase price down. Therefore, fast identification of these problems will help save you money and time...
 

somashekar

Staff member
Super Moderator
#4
We may be looking at acquiring a company. What are the main requirements of a due diligence as related to a medical device company? Would any of you have templates you could share with me, for checklists (technical, QA, RA) and for the final report?

Your speedy help is requested and will be highly appreciated.
MDD :
1. Notified body communication
2. Complete access and control to the TCF, ER checklist, test reports and the Risk management existing files.
3. Agreements with existing EU rep if any, and new registration of products as you are now the manufacturer.
4. Resolutions of any open reported complaints and its status
5. ISO 13485 certifying body communication, and continued ISO 13485 certificate.
6. CE certificates to your company now being the manufacturers after acquiring.

Other:
7. Information to Follow up services for the use of safety mark if any on the product.
8. 510 K transfer ... ? ( someone here can throw more light)
9. Health Canada licence details if this company had
 

bio_subbu

Super Moderator
#5
In addition to above replies, consider the following points in your Due diligence

What is the premarket review/approval requirement for the device, and has it been met?

Premarket notification (510(k)) exempt.

Premarket notification (510(k)) –obtain copy of letter showing the device has been deemed “substantially equivalent”

Premarket Approval (PMA)

Does the foreign manufacturer, and initial importer or distributor have a current establishment registration? You can be verified from FDA website: Establishment Registration & Device Listing

To what extent is compliance with FDA’s Quality system regulations (QSRs)/Good Manufacturing practices (GMP) required?

GMP Exempt (record keeping and complaint file requirements still apply)

Medical Device Reporting

Incidents in which a device may have caused or contributed to a death or serious injury must to be reported to FDA.

Mechanism for FDA and manufacturers to identify and monitor significant adverse events involving medical devices.

US Agent

Foreign manufacturers must also designate a U.S. Agent. The information on U.S. Agents can be found at:
http://www.fda.gov/MedicalDevices/D...urDevice/RegistrationandListing/ucm053196.htm

Compliance History of Manufacturer

What is the compliance history of the manufacturer, importer, and device?

Warning Letters

Recalls (Enforcement Report)

Is/has the device (been) subject to any of the following?

Import Alerts – used to initiate automatic used to detentions of regulated products

Import Refusal Reports – view by country or product

Establishment Inspection Reports (EIRs), EIRs are prepared by the FDA Investigator performing the inspection after every inspection. This Report details the inspection and findings, and includes exhibits to document findings.
 
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