Medical Devices
Are you looking for quality, regulatory or clinical support for your medical device? The QbD Group can support you at any stage in the lifecycle of your medical device, from idea to patient.
We are experts when it comes to ISO13485, clinical evaluation/investigation, MDR, design and development, technical files, auditing, qualification, validation, risk management, software, …
Discover more about what QbD can mean for your medical devices below.
Challenges in Medical Devices
Medical devices are regulated by laws that govern the safety and performance of devices across their lifetime, pre- and post-market. A risk-based classification system determines the pre- and post-market requirements for medical devices.
Medical devices with higher risks for the users require Notified Bodies to perform assessments on the safety and performance of the device. In this way, they ensure the continued safety and performance of medical devices, pre-, and post-market.
Manufacturers must ensure to only place medical devices in the market that comply with the legislative requirements. This requires documentation of the design, development, and manufacturing process of the device including sufficient clinical evidence that shows the device is safe and performs as intended.
By establishing a quality management system and documented procedures for manufacturing and post-market monitoring activities, the quality of the product is maintained leading to continued safety and performance of the medical device during its lifecycle.
Why QbD?
Within the QbD Group, we have the knowledge and expertise to support manufacturers, distributors, and importers of medical devices in complying with the legislative requirements during the complete lifecycle of a medical device.
Our clinical, regulatory, and quality experts know what needs to be done to be able to comply with the legislative requirements by which a medical device can be safely placed on the market.
Furthermore, we keep supporting businesses by managing the processes that ensure the medical device continues to be safe and effective, before and after placing it on the market.
QbD has experience with both start-up businesses and large multinationals. We are up-to-date with the latest changes in legislation/standards and can provide project management services.
Discover below some of the activities we can support you with:
- Outlining the regulatory pathway of your device to place it on the market
- Qualification and validation of your development, testing and manufacturing equipment and processes
- Building the technical file of your device
- Managing clinical investigations and writing clinical evaluation reports
- Data management of your clinical investigations
- Submitting your technical file to notified bodies
- Setting up, implementing and maintaining your quality management system
- Support with ISO13485 certification
- Validation of medical device software
- Performing audits internally or at suppliers
- Quality and regulatory management
- Training in ISO13485, MDR, Clinical, Qualification and Validation
We cover the full medical devices lifecycle
1. Building the business case
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:
- Ideation
- Market research
- Project timeline and costs
- Revenue research
- Creating a prototype
- Develop a regulatory plan
2. Product development phase
- Design control & documentation structure
- Design verification and validation
- Risk management
- Clinical evaluation and investigation
- Design transfer to manufacturing
- Qualification and validation of development, testing and manufacturing equipment and processes
- Software validation
- Build supplier and partner network
- Develop relationships with end users
- Regulatory submission
- Implement a Quality Management System
3. Product launch & post-market activities
- Set-up distribution network
- Reimbursement strategy
- Post-market clinical follow-up (PMCF)
- Post-market surveillance
- Regulatory management
- Maintain Quality Management System
- External inspections and internal audits
- Training
- Change management
1
Training
- ISO 13485:2016
- Medical Devices: roadmap to CE-marking
2
ISO 13485:2016
- Audits - Audit preparation
- QMS implementation
- eQMS solution: Scilife
3
Regulatory affairs & clinical solutions
- Technical documentation filling support
- MDR regulatory pathway
- IVDR regulatory pathway
- Clinical solutions:
- Data mgmt. statistics
- Project & Site mgmt.
- Regulatory CA, IRB/EC
- Safety, medical monitoring
- Compliance & medical writing
4
Device
- 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 Follow-up (PMCF)
- Person Responsible for Regulatory Compliance (PRRC)
Clients
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
Stay tuned on Medical Devices
Staying on top of the latest in the life science industry can be a daunting task. This newsletter will keep you up-to-date with the latest news, blogs and webinars so you can keep ahead of the curve.
Contact us
Don’t hesitate to contact us so we can listen to your needs and provide you with the right services.
