Clients enlist Vantage MedTech to compile US FDA 510(k) submission and CE Technical Files because of our diverse experience across devices and disciplines, our breadth and depth of institutional knowledge, field experience and peer review process. We prepare applications and technical dossiers for the US FDA, European Notified Bodies, Japan PMDA, Mexico COFEPRIS, Brazil ANVISA, Australia TGA, Health Canada and many other regulatory agencies worldwide.
Risk management is an integral part of the product design process but is often overlooked until the end of a project. Our systematic approach identifies, analyzes, evaluates, controls and monitors all types of medical device risks, throughout the product life cycle and post-market.
Essential for manufacturers of medical devices, our team assists with risk assessments and implementation of the following:
ISO 14971
IEC 62304
Software (ISO/TR/80002-2)
European Union Medical Device Regulation (EU MDR)
Medical Device Single Audit Program (MDSAP)
US FDA
We support all stages of pre-investigational activities, project management and monitoring, and post-market. surveillance of clinical studies which often may be required to show longer-term safety or effectiveness. We can help you formulate a comprehensive strategy for collecting clinical data needed to support regulatory.
Our human factors team assists our customers in meeting FDA guidance and IEC62336 for usability engineering. We work to understand the user-machine interface, assess overall risk, identify potential hazards arising from poor human factors, and ultimately validate the user experience through formative and summative testing.
Our expert Regulatory and Clinical team is here to ensure your success every step of the way. We help empower your journey with strategic guidance, ensuring regulatory compliance and successful market entry.
Our depth of expertise in specific clinical segments is strengthened by our dedicated team, refined processes, and specialized portfolio and proprietary platforms.
Reduce execution risk by working with a medical device software company known for over 1,600 medical devices successfully delivered.
Leverage our proprietary platform architecture and reduce development timelines by up to 60%.
Our in-house team of specialized engineers will bring your medical device from concept to reality with precision and care.
A medical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is—
A regulation is a written rule or guidance information issued by a government agency. A regulation that is a rule that has the force of law may be a standard or requirement of conduct which is set by a government agency under the statutory authority granted to it by Congress. In effect, Congress leaves the task of preparing and implementing details for a piece of legislation to the agency. A guidance regulation that does not have the force of law may simply be recommendations as to how to prepare a submission to the FDA though it may not intend to be the sole method for preparing the submission to the Agency.
Regulatory compliance must be established for medical devices to ensure patient safety, efficacy, and quality. It also facilitates market access by demonstrating that the device meets regulatory requirements, which is necessary for obtaining approvals or clearances to sell the device in specified markets.
Common regulatory requirements for medical devices include registration and listing, risk management classification (e.g., Class I, II, or III), quality management system (QMS) compliance (e.g., ISO 13485), premarket submissions (e.g., 510(k) clearance, PMA approval), labeling and packaging requirements, post-market surveillance, and adverse event reporting.
In order to improve its Risk Management System, the medical device manufacturer shall be able to estimate risks associated with the intended use of the medical device, as well as with a reasonably foreseeable misuse.
The Risk Management System shall be evaluated in the Post Market Surveillance system, focusing on hazards and frequency of risks occurrence.
Regulatory consultants provide expertise and guidance on navigating complex regulatory requirements. They assist with regulatory strategy development, premarket submissions, quality system implementation, compliance assessments, and ongoing regulatory support to ensure continued compliance with evolving regulations.
A regulatory pathway assessment outlines the approach and plan for achieving regulatory compliance for a medical device. It involves assessing regulatory requirements, determining the most appropriate pathway for market approval, and developing a roadmap to navigate the regulatory process efficiently. A well-defined regulatory pathway is essential for optimizing time-to-market and minimizing regulatory risks.
Non-compliance with regulatory requirements can have serious consequences, including delays in product approval or clearance, fines or penalties from regulatory agencies, product recalls, damage to brand reputation, and legal liabilities. Ensuring regulatory compliance is essential for maintaining market access and protecting patient safety.
Regulatory requirements for medical devices can change frequently due to advancements in technology, evolving safety standards, and updates to regulations by regulatory agencies. It is crucial for medical device manufacturers to stay informed about regulatory changes and proactively adapt their compliance strategies to remain compliant.
The advantage of such approach is that it provides the evidence that the Medical Device is safe and effective, without compromising the clinical condition or the safety and health of patients, users or, where applicable, of other persons.
If the Post Market Surveillance system is integrated with risk evaluation, any risks, potentially associated to the use of the Medical Device, is declared and could be acceptable if compared to its benefits and with a compatible high level of protection for what concerns both health and safety.
This is probably the most frequently asked question by start-up companies. They hear lots of things – both good and bad – about the pre-Sub or Q-Sub process. I have personally heard former FDA personnel – who have moved on to consulting roles – speak about pre-submissions, and they seem to have a negative opinion of the value of the process.
Many of these ex-FDA staffers worked for the agency when pre-submissions were known as a pre-IDEs and were used primarily for dialogue with the FDA about investigational device exemptions prior to a clinical trial. Since that time, pre-IDEs came to be used for other types of dialogue and, in the spirit of transparency and collaboration, became feedback on medical device submissions in final guidance from the agency, drafted in 2012 and finalized in 2014 (and then updated in 2017).
First, preparing the pre-Sub package requires a company to gather information and describe the device and its use for the FDA. This often reveals gaps in understanding that can be remedied earlier in the development process.
The second advantage of putting the pre-Sub together is the careful formulation of questions for the FDA. Remember, we don’t ask open-ended questions like, “What kind of clinical trial would the FDA like to see for this type of product.” Rather, do the work of crafting a draft clinical plan to include in the pre-Sub package, and ask the FDA if they agree with the plan. The more we can “think like the regulators,” the better chance we have of an expedient clearance or approval.
Section 524B(a) of the FD&C Act provides that the sponsor of a premarket submission for a cyber device must include information to demonstrate that the cyber device meets the cybersecurity requirements in section 524B(b) of the FD&C Act. The requirements in section 524B(b) of the FD&C Act are:
The FDA may also issue regulations with other requirements to demonstrate reasonable assurance that the device and related systems are cybersecure. See FAQs 6 through 9 for additional details on ways manufacturers might demonstrate that their devices are cybersecure.
Section 524B(c) of the FD&C Act defines "cyber device" as a device that (1) includes software validated, installed, or authorized by the sponsor as a device or in a device, (2) has the ability to connect to the internet, and (3) contains any such technological characteristics validated, installed, or authorized by the sponsor that could be vulnerable to the cybersecurity threats. If manufacturers are unsure as to whether their device is a cyber device, they may contact the FDA.