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20+ YEARS OF INDUSTRY EXPERIENCE

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AUDIT AND CONSULTANCY

20+ YEARS OF INDUSTRY EXPERIENCE

MAINTAIN YOUR POSITION

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Why Due Diligence audits?

Quality-Audit

There is a quite simple reason why companies should consider a Due Diligence Audit.

Medical Device companies operate in a very heavily regulated global environment. Therefore the ability of a company to meet those requirements is often what determines a company’s potential and profitability. Due diligence audits helps a manufacturer in evaluating the potential of a target company. When considering the acquisition of a medical device manufacturer there are a lot of things to consider, not only financial, business and legal issues.

Amongst other things the following areas are in need of evaluation:

  • What regulations and standards the device must live up to.
  • Regulatory Due Diligence
  • Quality Due Diligence
  • Facility / Equipment Assessment
  • Personnel Assessment
  • Post-Merger Integration
  • Open FDA inspection observations or warning letters
  • Pending submissions
  • Major design changes – are the changes controlled adequately? Have they been submitted?
  • Incomplete or limited product approvals
  • Uncontrolled or mismanaged production activities
  • Adverse events or field corrections

A Due Diligence Audit with a thorough review of all of these points are essential for reducing the risk for a potential buyer of medical device companies.

Due Diligence Audits are confidential

Due to the highly confidential nature of M&A financial advisers are normally used to limit the knowledge internally in the acquiring company. These companies are specialised in the financial, business, and legal issues involved in the merger and acquisition of companies of all sorts.

However, not all of these companies consider the need for a certified, competent Lead Auditor specialised in medical devices who is used to working in settings where confidentiality is essential. Too often the compliance evaluation of the potential target is left to the acquiring company or even overlooked.

As a potential buyer you have the right to request and choose the right competence for this part of the due diligence audit, to provide you with the most relevant evaluation of these critical points. Without this how do you really know the real state of compliance for your target company?

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Why use an external auditor for due diligence audits?

Consider if your M&A partner is able to help you determine the following from a Regulatory point of view:

  • Is the system compliant to MDSAP, Medical Device Regulation 2017/745 (MDR)?
  • What is the status of Device approvals, Licenses and Certifications?
  • Does the target company have an appropriate QMS in place?
  • What are the results of regulatory and QMS audits by outside authorities?
  • What are the results of Internal audits?
  • Is the internal audit program adequate?
  • Are all products and processes properly validated?
  • Is all relevant software validated?
  • Subcontractors and suppliers. Are they adequately selected, controlled, and re-evaluated?
  • Are the quality agreements in line with regulatory requirements?
  • What is the status of complaints and non-conformities?
  • Are there any recalls, adverse events, advisory notices, etc.?
  • What is the status of CAPA’s? Is the CAPA process effective?
  • Are distribution activities adequately controlled?

If the answer to the above questions is NO, then you should consider choosing an external auditor for your due diligence audit. This will provide you with an unbiased evaluation, as the objective for the consultant is to provide you with the evaluation that you need to determine the feasibility of the acquisition target in terms of regulatory and QMS compliance.

If you as a buyer will need to correct any of these regulatory problems, this evaluation will help to adjust the purchase price down. It will also allow you to plan the merger in a more efficient way.

Fast identification of these problems will help save you money and time.

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Services

Quality-Audit provides independent, professional and discreet consulting services for the medical device industry.

Whether your company is a start-up or a global company Quality-Audit is able to help, both on-site and remote.

If what you are looking for is not listed, please send our team a message by clicking here.

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  • Auditing

    Former Lead Auditor for a Notified Body, with experience from over 50 NB audits.

  • Consulting

    Quality-Audit offers medical device consulting on compliance related tasks.

Services

Quality-Audit provides independent, professional and discreet consulting services for the medical device industry. Whether your company is a start-up or a global company Quality-Audit is able to help, both on-site and remote.

If what you are looking for is not listed, please send our team a message by clicking here.

BOOK A FREE CONSULTATION

What sets us apart?

Audits are challenging for organizations, but Quality-Audit can help ease the burden, whether you are looking for a mock audit or wish to outsource your internal and supplier audits. With 20+ years of industry experience and Notified Body experience we have seen it all. Are you struggling with audit challenges? Book a video consultation, so we can address your needs and issues.

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What our clients have to say…


Quality Director, Danish Medical Device company.

Very good mock audit to MDSAP and MDR. Gert was very pleasant and efficient.

Quality Manager, German start-up.

It was a pleasure being audited by Gert. He was able to provide not only the audit we needed, but also the coaching we were hoping for. It was a good mock audit.

Managing director, Dutch start-up.

Highly effective internal audit mdd/iso 13485.

Quality Director, Fortune 500 Company

Just a personal note of thanks for the collaborative approach throughout the audit and for all the great feedback to the team. Hopefully we get to meet in person sometime in the future.

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Small Business Websites

Corporate Websites

E-commerce Websites

Small Business Websites

Corporate Websites

E-commerce Websites