EXPERT KNOWLEDGE
Medical Devices and In Vitro Diagnostics
We support from concept to launch in the full lifecycle.
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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.
Training
ISO 13485:2016
Medical Devices: roadmap to CE-marking
ISO 13485:2016
Audits – Audit preparation
QMS implementation
eQMS solution QualityKick
Regulatory affairs & clinical solutions
Technical documentation filling support
MDR (MDD) regulatory pathway
IVDR guidance
Clinical solutions:
Device manufacturing – start
Process development
Equipment Qualification
Process Validation
QA support
Software validation
Post Market Support
Production support
QA support
Quality event management
Inspections and audits
Post-market surveillance (PMS)
Post-market clinical data
…
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 > ISO13485
Product certification > CE mark / De Novo / 510K > technical file preparation and submission
MDD & MDR > complying with Medical Device Regulation requirements
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!
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.
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:
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:
Receive detailed information from one of our medical device experts.
