Medical Devices
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 – each define four different classes of devices ranging from low to high risk.
Under the EU Medical Devices Regulation 2017/745 (MDR) is 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
Services we offer
1
Product Development
services
- Design control & documentation structure
- Design Verification and Validation
- Risk management
- Build supplier and partner network
- Quality Management System implementation
2
Regulatory Affairs
& Clinical Solutions
- MDR regulatory pathway
- IVDR regulatory pathway
- Technical documentation filling support
- Qualification & classification of SW as a Medical Device
- Clinical solutions:
- Data mgmt. statistics
- Project & Site mgmt.
- Regulatory CA, IRB/EC
- Safety, medical monitoring
- Compliance & medical writing
3
Product Registration Process
- Process development
- Equipment Qualification
- Process Validation
- QA support
- Software Validation
- Technical Documentation set-up
- Support for 510k and PMA process (FDA)
4
Design Transfer & Manufacturing
- Production support
- QA support
- Quality event management
- Inspections and audits
- Post-market surveillance (MPS)
- Post-market clinical data
- Technical Documentation set-up and maintenance
ISO 13485:2016
- Audits - Audit preparation
- QMS implementation
- eQMS solution: Scilife
Training
- ISO 13485:2016
- Medical Devices & IVDs: roadmap to CE-marking
- Medical Device Software (MDSW)
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!
- Legal manufacturer
- Legal representative
- Distributor
- Contract manufacturer
- Assembler
- Third-party logistics
- Importer
Step 1: Building the business case
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.
- Ideation
- Market research
- Project timeline and costs
- Revenue research
- Creating a prototype
- Develop a 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.
Step 2: Product development phase
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 and Risk Management are crucial. We support you on the following topics:
- Design control & documentation structure
- Design Verification and Validation
- Design transfer
- Risk management
- Build supplier and partner network
- Develop relationships with end users
- Regulatory submission
- Quality Management System implementation
Step 3: Product launch & post-market activities
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
- Reimbursement strategy
- Manage quality events
- Post-Market Clinical follow-up (PMCF)
- Maintain quality management system
- External inspections and internal audits
- Training
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.
