Medical devices and in vitro diagnostics

medical devices in vitro diagnostics

The regulations on Medical Devices (MDs) and In Vitro Diagnostics (IVDs) – i.e. hardware and software used for medical proposes – define four different classes of devices ranging from low to high. Under the EU Medical Devices Regulation 2017/745 (MDR) that will be effective as of 26 May 2021, the definition of an MD and the scope of the legislation is broadened. Not only manufacturers of medical devices, but also importers, distributors and assemblers will fall under the Medical Devices Regulation, including cosmetic solutions.

The Medical Devices and In Vitro Diagnostics industry is subject to an ever-increasing complexity. The manufacturing and validation of MDs and IVDs entails a wide variety of challenges. We are more than happy to support you in one of the following subjects, or another topic related to MDs and IVDs:

  • Quality Management > ISO13485
  • Product certification > CE mark / De Novo / 510K > technical file preparation and submission
  • MDD & MDR > complying to Medical Device Regulation requirements
  • MDSAP
  • FDA / EU

Step 1: Building
the business case

Ideation and feasibility

From concept to launch, we capture all the phases in the Medical Devices lifecycle with the help of our extended partner network. We can help you build your business case from idea to market and revenue research, define your business strategy and risk management and guide you through the entire product life cycle.

  • Ideation
  • Market research
  • Project timeline and costs
  • Revenue research
  • Creating a prototype
  • Develop regulatory plan

Select markets of interest (determining US and/or EU classification)
Together with our dedicated partners, we predefine the minimal deliverables for your Medical Devices development strategy in our development scan, including the following phases:

medical devices schema building business case

medical devices schema product development phase

Step 2:
Product development phase

Design & development | verification & validation | design transfer

QbD is aimed at helping patients benefit from new devices as quickly as possible. To ensure the quality, safety and efficacy of MDs and IVDs, thorough Quality Management (QM) and Risk Assessment (RA) are crucial. We support you on the following topics:

Step 3: Product Launch
& Post-market activities

Device production | Post market | Device obsolescence

We offer full guidance for companies to bring a product to the market and support you during the commercial phase and post-market activities. Think about ensuring a robust post-market surveillance process, including clinical follow-up and vigilance. Our activities include:

  • Set-up distribution network
  • Develop marketing materials
  • Product registration
  • Reimbursement strategy
  • Manage quality events
  • Maintain quality management system
  • External inspections and internal audits
  • Training
medical devices schema product launch post market activities

Medical Devices ECOSYSTEM

Is your company active in one of the following businesses or related businesses? And are you in search of support in the field of Medical Devices and In Vitro Diagnostics? Please get in touch with one of our experts!

  • Marketing Authorisation Holder (MAH) with all activities outsourced
  • Legal representative
  • Distributor
  • Contract manufacturer
  • Assembler
  • Third-party logistics
  • Importer

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