The Medical Device Lifecycle – Bringing your Medical Device to Market
The process of bringing a new medical device to market has a number of important milestones. In addition to designing a good product, it is important to anticipate many of the requirements that will allow you to introduce it successfully.
Regardless of where you are in the process, whether this is your first medical device to market or you are involved in the management of an extensive product line, Aptiv Solutions can help ease your regulatory, clinical trial, and quality assurance burdens, allowing you to focus your time and resources on achieving your future business goals.
Medical device design and prototype
- Assess the impact of regulatory environment and FDA policies
- Assess applicable Medical Device Directives and individual country requirements
- Determine product classification and essential requirements
- Identify FDA Center jurisdiction for combination products
- Design and review your pre-clinical test plans and clinical studies
- Evaluate technical and clinical data, labeling reviews and risk management
- Prepare for and facilitate pre-IDE / pre-submission meetings and communications
- Liaison with Notified Bodies and Competent Authorities
- Define and assess product labeling claims and clinical data requirements
Validation and verification testing
During the next phase of device development, you will be working to further evaluate, verify, and validate, and if successful, freeze your device design through pre-clinical and early feasibility testing.
At this stage, you may need to refine or further develop your regulatory strategy based on the results obtained during pre-clinical testing. You will be developing systems and processes to document your development process. You may need to further identify or refine specific user requirements and technical specifications, along with initiating a preliminary medical device risk analysis.
During the validation and verification stage, Aptiv Solutions can help you to:
- Develop and implement systems and procedures to document design history process
- Implement risk management and design validation processes and procedures
- Identify testing standards and requirements for your technology
Preclinical and clinical trials
After initial design and prototype activities, and as your project proceeds, you will begin to conduct pre-clinical tests and clinical trials and collect appropriate data to support your study endpoints. Aptiv Solutions will help you to ensure that the appropriate testing is conducted and that your study data is presented in the most appropriate formats for the regulatory agencies and others.
Our project managers will oversee day-to-day study activities, giving you confidence that all the relevant data are captured, collected, and interpreted to support your study goals. Your project manager will assist the clinical sites with submissions to the appropriate Institutional Review Boards (IRBs), Ethics Committees, and the FDA and international regulatory bodies to facilitate the approval process, provide routine reporting on study progress to keep you apprised of data accrual and data quality on a site-by-site basis, and keep you and your study team on track with regular communication. We will work with you to:
- Define appropriate pre-clinical and bench studies
- Develop a clinical trial design, prepare study protocols and study documents
- Identify study sites
- Obtain regulatory / IRB / Ethics Committee (EC) approvals
- Collect, manage, and monitor clinical trial data
- Perform statistical analysis
- Prepare clinical study report
- Design and implement a quality system to meet FDA, QSR and ISO 13485
Regulatory Clearance / Approval
In order to gain medical device regulatory clearance or approval, you will need to meet specific criteria set forth by all of the appropriate regulatory bodies. You will also need to preserve the integrity of your manufacturing process as you scale up for production. Aptiv Solutions can prepare you and your facilities for possible regulatory audits, including FDA inspections and registrar or Notified Body assessments.
For clients based outside the United States seeking medical device regulatory approval, we can serve as your FDA U.S. Agent. For clients based outside of Europe, we can help you to identify a European Authorized Representative.
Aptiv Solutions will help you to write, assemble, and submit effective medical device regulatory documents, including:
- 510(k) Premarket Notifications (traditional, special, abbreviated)
- Premarket approval (PMA) applications, amendments and supplements
- Design Dossiers and Technical Files for CE Marking
- Manufacturing and software information for FDA
- Device reclassification petitions
- Master files
- Canadian Device License applications
- Establishment Registration
- Device Listings
Postmarket & Compliance Activities
You have successfully entered the marketplace, but conditions are constantly changing and your ability to maintain product viability is regularly challenged. Perhaps you are planning to expand your marketing, introduce enhancements or changes to your device, its labeling or instructions. You may be concerned about successfully managing your postmarket surveillance efforts. Aptiv Solutions can help you to plan and manage all of these challenges. Our consultants have the knowledge and expertise necessary to help you to:
- Perform EU Vigilance Reporting
- Respond to FDA 483s and Warning Letters
- Develop regulatory strategies to address future product and labeling changes
- Prepare Traditional or Special 510(k) submissions for new devices or existing device modifications
- Assess and understand any applicable European Medical Device Directives and individual country requirements to support international market introductions
- Design, manage, and monitor any clinical studies you may need to support future submissions or to meet any post-market requirements
- Prepare your team for FDA inspections and registrar or Notified Body assessments
- Manage your post-marketing surveillance requirements, include complaint handling, medical device reporting (MDR), vigilance reporting, failure investigations, problem reporting and device tracking