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.

All other devices

Challenges in Medical Devices

DISCOVER MORE ON THE INDUSTRY

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?

YOUR MEDICAL DEVICES INDUSTRY EXPERT

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:

Medical devices

We cover the full medical devices lifecycle

FROM IDEA TO PATIENT

Services we offer

1

Product Development
services

2

Regulatory Affairs
& Clinical Solutions

3

Product Registration Process

4

Design Transfer & Manufacturing

ISO 13485:2016

Training

1

Training

2

ISO 13485:2016

3

Regulatory affairs & clinical solutions

4

Device

5

Post-Market Support

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 FEASIBILITY
DESIGN & DEVELOPMENT | VERIFICATION & VALIDATION | DESIGN TRANSFER
DEVICE PRODUCTION | POST-MARKET | DEVICE OBSOLESCENCE
Business case
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 which includes conducting revenue research, defining your business strategy and risk management, and guiding 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:

  • Ideation
  • Market research
  • Project timeline and costs
  • Revenue research
  • Creating a prototype
  • Develop a regulatory plan
Product development
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
Product launch
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

Stay tuned on Medical Devices

WE SHARE THE LATEST NEWS

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

TALK TO AN EXPERT

Don’t hesitate to contact us so we can listen to your needs and provide you with the right services.

Related articles

DISCOVER OUR LATEST ARTICLES ON MEDICAL DEVICES

Related whitepapers

DISCOVER ALL OUR FREE MD WHITEPAPERS

MDR 2017/745: a brief introduction

IVDR 2017/746 - How to prepare for compliance?

Mobile applications and compliancy