EXPERT KNOWLEDGE

Medical Devices and In Vitro Diagnostics

Let’s get your medical device to market. We support you from concept to launch in the full lifecycle.

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 risk. 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 certain cosmetic solutions.

We cover the full Medical Devices
& In Vitro Diagnostics lifecycle

1

Training

2

ISO 13485:2016

3

Regulatory affairs & clinical solutions

4

Device manufacturing – start

5

Post Market Support

Key services

The manufacturing and validation of medical devices and IVDs entail 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
    Product certification > CE mark / De Novo / 510K > technical file preparation and submission

  • MDD & MDR
    Complying with Medical Device Regulation requirements
  • FDA / EU

  • MDSAP
  • End-to-end project execution
  • Advice & strategy on regulatory requirements
  • Clinical strategy

clients

Key partner in the medical device 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? Let’s talk!

Ideation and feasability

Step 1: Building the business case

Ideation and feasability

From concept to launch, we capture all the phases in the Medical Devices lifecycle with the help of our extended partner network.

We 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.

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 device Design & development | verification & validation | design transfer

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:

Device production | Post-market | Device obsolescence

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:

The manufacturing and validation of MDs and IVDs entails a wide variety of challenges. We're here to help.

Contact

Talk to an expert

Receive detailed information from one of our medical device experts.

Upcoming Webinars

Medical devices: urgent needs vs regulation​
Thursday, 25 Feb 2021, 5:00 PM

Learn about early verification in a stringent design control process to decrease Time to Market and master the full product lifecycle of medical devices, not the least in pandemics like COVID-19.​​​​​​​ ​​​​​​​

Featured content

The Pathway from Idea to Patient

Related Whitepapers

IVDR 2017/746 - How to prepare for compliance?

MDR 2017/745: a brief introduction

Checklist MDR implementation

Checklist ISO13485

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