Regulatory Due Diligence

Regulatory Due Diligence

Are you interested in buying the rights of a medical device, a combination product, a technology or an entire company or are you planning to invest in a startup?

We help our customers compare the relevant technological and regulatory requirements with the current status and carry out an assessment.

 

Frequently Asked Questions are:

  • Clarification of the classification and the possible approval procedures
  • Uncertainty concerning applicable regulatory and normative requirements
  • Does the technical file (DHF and DMR) comply with the relevant requirements?
  • Does the quality management system satisfy the regulatory requirements and is it effective?
  • Which possibilities of cost reduction are there in the supply chain, the manufacturing process and the release process?
  • Is the product producible in the desired quantities?

Many company mergers, acquisitions and investment breakdowns can be attributed to the fact that only the finances, patents and contracts are intensively screened during due diligence. The objective of the investment is often forgotten, namely the product! Our private equity/venture capital clients are impressed.

When is it important?

Technical and regulatory due diligence analyses a product, the subject matter of an investment, but can also be relevant to an acquisition or a merger.

All services

Article 117 is applicable for devices which are intended to administer a medicinal product and where the medicinal product is placed on the market in such a way that they form a single integral product which is intended exclusively for use in the given combination and which is not reusable. In this case the combined product is governed by Directive 2001/83/EC or Regulation (EC) No 726/2004, as applicable.

Since the publication of 21 CFR Part 4, we have supported numerous customers proactively in the implementation of appropriate requirements.

One of confinis’ key competencies lies in the design control procedure for medical devices and combination products.

Risk management is a central process throughout the development and the entire product lifecycle. We help create a complete risk management file by combining risk management with usability engineering/human factors and additional normative requirements.

The usability engineering procedure is closely linked to the risk management process.

confinis can create a clinical evaluation for your medical device, which is required for regulatory purposes or can help you define and implement relevant internal procedures.

Knowledge and experience from confinis concerning combination products are globally unique and make confinis a valued partner.

confinis in-vitro diagnostic medical device experts will help you with all steps of IVDR implementation and certification of your devices

The product classification is key to identify the relevant regulations and standards as well as requirements for evidence and documentation needed for product launch in selected markets.

confinis has a broad experience in establishing product technical documentation and submission files for CE marking, FDA submissions and submissions to authorities globally.

A performance evaluation is an assessment and analysis of data related to a specific IVD device.

Confinis can advise you on how to identify the correct classification of your software and determine requirements for development, testing, and documentation as well as cybersecurity and data protection.

Digital Health solutions can revolutionize lives of patients globally and disrupt your business. An effective and efficient approach to digital health with appropriate procedures and technical know-how provides plenty of support for the development of qualitative and highly valued products.

We are happy to support you with our experience in developing the right packaging for your products and customers.

Nothing simply Improves on its own, but you can actively make everything better – confinis will gladly assist you to increase your added value!

We determine for our customers how the relevant app is classified in different markets and what effects this will have on the development, testing and documentation.

One of confinis’ key competencies lies in the design control procedure for medical devices and combination products.

Risk management is a central process throughout the development and the entire product lifecycle. We help create a complete risk management file by combining risk management with usability engineering/human factors and additional normative requirements.

The usability engineering procedure is closely linked to the risk management process.

confinis can create a clinical evaluation for your medical device, which is required for regulatory purposes or can help you define and implement relevant internal procedures.

We help our customers compare the relevant technological and regulatory requirements with the current status and assess the situation.

Knowledge and experience from confinis concerning combination products are globally unique and make confinis a valued partner.

confinis has years of experience from the soft improvement up to the complete remediation of development documentation of various medical devices, the so-called Design History File (DHF).

confinis gladly supports you with risk-based, efficient implementation of the normative requirements and combines these with a suitable software development procedure.

Together with an IT partner we developed, validated, and certified an electronic quality management system based on the software platforms Jira and Confluence.

We support the manufacturers with the implementation and set-up of the relevant processes. This could be general procedures or product specific postmarket surveillance plans.

Our goal is to prepare your team until they know that they will succeed and look forward to prove their competences.

confinis has years of experience with the risk-based and efficient validation of manufacturing processes in regulated environments.

confinis uses trained auditors that clarify processes and point out improvement potential.

We will gladly work on a training concept with you and develop a training process tailored to your company’s size and existing knowledge.

A core competency of confinis lies in the construction of quality management systems according to EN ISO 13485, and 21 CFR Part 820, respectively, for the US market.

One of confinis’ key competencies lies in the design control procedure for medical devices and combination products.

Digital Health solutions can revolutionize lives of patients globally and disrupt your business. An effective and efficient approach to digital health with appropriate procedures and technical know-how provides plenty of support for the development of qualitative and highly valued products.

Article 117 is applicable for devices which are intended to administer a medicinal product and where the medicinal product is placed on the market in such a way that they form a single integral product which is intended exclusively for use in the given combination and which is not reusable. In this case the combined product is governed by Directive 2001/83/EC or Regulation (EC) No 726/2004, as applicable.

The implementation of various requirements of the national authorities often represents major challenges to the international distribution of medical devices and combination products and requires extensive know-how of country-specific requirements. Market authorizations in target markets are coordinated with the help of the Regulatory Affairs Strategy.

confinis has extensive experience in developing suitable, regulatory-compliant strategies for attaining CE-certification, which is necessary for the introduction of medical devices in the European Union.

The employees at confinis have substantial knowledge regarding the regulatory approvals of medical devices in the US.

Our consultants at confinis can support you with their experience of product approvals in Asia, South America, etc.

Manufacturers of medical devices that are located outside of the EU and its contracting countries (such as Switzerland), require an agent (also known as an “Authorized Representative”). confinis can assume this function for you.

Foreign manufacturers of medical devices, including key suppliers, who wish to sell their products in the United States must designate a “U.S. Agent” residing in the US. We are able to fill that role and act as a U.S. Agent for you.

We are confinis. How can we help you?

Call us at a confinis office nearest to you or send us a message online.

We are very happy with our choice of confinis as a one stop shop QA/RA partner to Neo Medical, supporting our growth from a start-up to an international company. confinis has provided expertise in everything from quality management, design control, clinical evaluation, internal and supplier audits, CE marking, 510(k)s to global registrations. I highly recommend confinis!

Jonas Larsson
CEO, Neo Medical

Looking for efficient and effective advice on medical devices and combination products?