EXPERT KNOWLEDGE

Medical Devices and In Vitro Diagnostics

We support 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. 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.

We cover the full Medical Devices
& In Vitro Diagnostics lifecycle

1

Training
ISO 13485:2016
Medical Devices: roadmap to CE-marking

2

ISO 13485:2016
Audits – Audit preparation
QMS implementation
eQMS solution QualityKick

3

Regulatory affairs & clinical solutions
Technical documentation filling support
MDR (MDD) regulatory pathway
IVDR guidance
Clinical solutions:

4

Device manufacturing – start
Process development
Equipment Qualification
Process Validation
QA support
Software validation

5

Post Market Support
Production support
QA support
Quality event management
Inspections and audits
Post-market surveillance (PMS)
Post-market clinical data

Our services

The manufacturing and validation of MDs 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

Quality Management > ISO13485

Product certification

Product certification > CE mark / De Novo / 510K > technical file preparation and submission

MDD & MDR

MDD & MDR > complying with Medical Device Regulation requirements

MDSAP

End-to-end project execution

Advice & strategy on regulatory requirements

Clinical strategy

for who

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.​​​​​​​ ​​​​​​​

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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