Medical device regulation
Medical device regulation
We review your medical device to ensure conformity with the relevant regulations by offering a range of product review services to bring your device to the market.
Our team of medical device and IVD regulatory experts offers in-depth guidance on relevant regulations and requirements, going beyond standard published materials. We partner with you to create and execute a competitive and cost-effective regulatory strategy, prepare and submit a marketing application that resonates well with reviewers, and act as your liaison throughout the process, facilitating efficient and effective negotiations with the FDA, EU, UK, and other international regulatory agencies.
Global experts in regulatory affairs
Global experts in regulatory affairs
A well-crafted regulatory strategy carefully considers the regulatory requirements for the target markets, as well as development costs, timelines, and profitability concerns. We always take into account the current regulatory environment, relevant regulations, and ongoing initiatives that could impact your regulatory pathway. Our regulatory experts are highly respected by healthcare authorities and have built strong relationships with agency leaders and reviewers through years of professional experience and regular interactions.
Our medical device regulatory experts consider information about your medical device including
Device description and specifications
We start by gathering detailed information about your medical device—its design, components, how it works, and the materials used. This helps us get a clear picture of what makes your device unique and how it functions in a healthcare setting.
Intended clinical application(s)
Next, we explore how your device will be used in real-life medical situations. Whether it’s treating a specific condition or helping a certain group of patients, we ensure your device’s clinical applications are well understood.
Labelling claims
Your device comes with important claims about what it does and its benefits. We review these claims to ensure they’re backed by solid evidence, so healthcare providers and patients can trust the results your device promises.
Available preclinical and clinical information
We dive into the research and data from any lab tests or clinical trials that have been done on your device. This helps us confirm its safety and effectiveness, providing a strong foundation for regulatory approval.
Software and cybersecurity documentation
For devices that include software, we take a close look at how it’s built and how secure it is. We ensure your software is not only effective but also protected against cybersecurity threats, so sensitive health data stays safe.
Literature references
We gather all the relevant scientific research that supports your device. These studies and papers help reinforce your device’s claims and demonstrate its value to healthcare professionals and regulatory bodies.
Device description and specifications
We start by gathering detailed information about your medical device—its design, components, how it works, and the materials used. This helps us get a clear picture of what makes your device unique and how it functions in a healthcare setting.
Intended clinical application(s)
Next, we explore how your device will be used in real-life medical situations. Whether it’s treating a specific condition or helping a certain group of patients, we ensure your device’s clinical applications are well understood.
Labelling claims
Your device comes with important claims about what it does and its benefits. We review these claims to ensure they’re backed by solid evidence, so healthcare providers and patients can trust the results your device promises.
Available preclinical and clinical information
We dive into the research and data from any lab tests or clinical trials that have been done on your device. This helps us confirm its safety and effectiveness, providing a strong foundation for regulatory approval.
Software and cybersecurity documentation
For devices that include software, we take a close look at how it’s built and how secure it is. We ensure your software is not only effective but also protected against cybersecurity threats, so sensitive health data stays safe.
Literature references
We gather all the relevant scientific research that supports your device. These studies and papers help reinforce your device’s claims and demonstrate its value to healthcare professionals and regulatory bodies.
We review and identify potential predicate devices, standard methods, procedures, and applicable regulations and policies. Based on this information, our team of experts will recommend the market entry strategy for the target markets and outline the required technical, preclinical, and clinical information.
Submission process
Submission process
Our experts have prepared and submitted more than 100 successful medical device regulatory documents for US, EU, and global clients, including
Pre-submission support documents
We guide you through the early stages of regulatory submission by helping you prepare the necessary pre-submission documents. This ensures your device is positioned for success from the start, giving you confidence in your regulatory journey.
510(k) Premarket Notifications
For devices heading to the U.S. market, we help you navigate the 510(k) Premarket Notification process. This allows your device to prove it’s substantially equivalent to an existing, legally marketed device, speeding up your approval and market entry.
Investigational Device Exemption Applications (IDEs), Clinical Trial Authorisations (CTAs), Investigational Testing Authorisations (ITAs)
If your device needs clinical testing, we manage the complex applications required to get approval for trials. Whether in the U.S., EU, or elsewhere, we handle the regulatory paperwork for IDEs, CTAs, and ITAs, ensuring smooth approval for clinical studies.
De Novo Classification Requests
For innovative devices with no existing equivalent, we help you through the De Novo classification process. This allows your device to be categorized under a new classification, opening the door to the market as a first-of-its-kind product.
Premarket Approval Applications (PMAs)
For high-risk devices, we prepare your Premarket Approval Application (PMA). This in-depth submission is required to demonstrate that your device is safe and effective, and we make sure it meets the strict requirements of regulatory bodies.
513(g) Requests for Classification
Not sure how your device is classified? We help you submit a 513(g) request to the FDA, so you can get official feedback on the regulatory path for your device, whether it’s a new technology or a modification of an existing one.
Technical Documentation for CE Mark
To sell your device in Europe, it needs a CE Mark. We prepare the technical documentation to show that your device meets EU safety, health, and environmental standards, paving the way for your entry into the European market.
Clinical Publication Planning, Scientific Communications
Dissemination of medical information
To satisfy stakeholders’ various demands, our medical affairs team focuses on providing medical information services and promoting scientific exchange.
- KOL profiling, CME support, Ad-boards
- Consensus documents
- Medical education and training
- Physician perception mapping
Pre-submission support documents
We guide you through the early stages of regulatory submission by helping you prepare the necessary pre-submission documents. This ensures your device is positioned for success from the start, giving you confidence in your regulatory journey.
510(k) Premarket Notifications
For devices heading to the U.S. market, we help you navigate the 510(k) Premarket Notification process. This allows your device to prove it’s substantially equivalent to an existing, legally marketed device, speeding up your approval and market entry.
Investigational Device Exemption Applications (IDEs), Clinical Trial Authorisations (CTAs), Investigational Testing Authorisations (ITAs)
If your device needs clinical testing, we manage the complex applications required to get approval for trials. Whether in the U.S., EU, or elsewhere, we handle the regulatory paperwork for IDEs, CTAs, and ITAs, ensuring smooth approval for clinical studies.
De Novo Classification Requests
For innovative devices with no existing equivalent, we help you through the De Novo classification process. This allows your device to be categorized under a new classification, opening the door to the market as a first-of-its-kind product.
Premarket Approval Applications (PMAs)
For high-risk devices, we prepare your Premarket Approval Application (PMA). This in-depth submission is required to demonstrate that your device is safe and effective, and we make sure it meets the strict requirements of regulatory bodies.
513(g) Requests for Classification
Not sure how your device is classified? We help you submit a 513(g) request to the FDA, so you can get official feedback on the regulatory path for your device, whether it’s a new technology or a modification of an existing one.
Technical Documentation for CE Mark
To sell your device in Europe, it needs a CE Mark. We prepare the technical documentation to show that your device meets EU safety, health, and environmental standards, paving the way for your entry into the European market.
Clinical Publication Planning, Scientific Communications
Dissemination of medical information
To satisfy stakeholders’ various demands, our medical affairs team focuses on providing medical information services and promoting scientific exchange.
- KOL profiling, CME support, Ad-boards
- Consensus documents
- Medical education and training
- Physician perception mapping
Authorized representative
Authorized representative
FDA Establishment Registration/ Device Listing activities
We manage the registration of your manufacturing facility and device listings with the FDA. This crucial step ensures that your medical devices are legally recognized and compliant with U.S. regulatory requirements.
FDA US Agent for Foreign Establishments
If your company is based outside the U.S., we act as your official FDA U.S. agent. We handle all communication with the FDA on your behalf, making sure you stay compliant with regulations while expanding your reach into the U.S. market.
EU Authorised Representative for CE Marked Devices
For non-EU companies, we serve as your authorized representative in the EU, ensuring your medical devices meet all regulatory requirements for CE Marking. This allows your products to be sold legally across Europe while maintaining compliance with EU laws.
EU Legal Representative for Medical Device Trials
We act as your legal representative for clinical trials within the EU, helping you navigate complex regulations. This ensures that your medical device trials are conducted in full compliance with European laws, from initiation to approval.
FDA Establishment Registration/ Device Listing activities
We manage the registration of your manufacturing facility and device listings with the FDA. This crucial step ensures that your medical devices are legally recognized and compliant with U.S. regulatory requirements.
FDA US Agent for Foreign Establishments
If your company is based outside the U.S., we act as your official FDA U.S. agent. We handle all communication with the FDA on your behalf, making sure you stay compliant with regulations while expanding your reach into the U.S. market.
EU Authorised Representative for CE Marked Devices
For non-EU companies, we serve as your authorized representative in the EU, ensuring your medical devices meet all regulatory requirements for CE Marking. This allows your products to be sold legally across Europe while maintaining compliance with EU laws.
EU Legal Representative for Medical Device Trials
We act as your legal representative for clinical trials within the EU, helping you navigate complex regulations. This ensures that your medical device trials are conducted in full compliance with European laws, from initiation to approval.
Other services
Other services
We optimize reimbursement paths while guaranteeing regulatory compliance and market readiness. Our strategy planning facilitates a seamless market launch and long-term success.
SaMD, Digital Therapeutics
Medical disorders are treated, managed, and prevented with specialized therapy modalities. To deliver evidence-based treatment interventions, each DTx digital health product is created by fusing digital innovation with medical experience. We guarantee that every product is both legally compliant and produces significant health benefits. Read More
Quality Assurance, Testing
Medical device companies trust us to meet or exceed the QA standards of EMA, FDA, MHRA, and other regulatory agencies. You can navigate the procedures for medical device product review, approval, and regulatory compliance with the support of our global experience working with regulators and Notified Bodies. Read More
SaMD, Digital Therapeutics
Medical disorders are treated, managed, and prevented with specialized therapy modalities. To deliver evidence-based treatment interventions, each DTx digital health product is created by fusing digital innovation with medical experience. We guarantee that every product is both legally compliant and produces significant health benefits. Read More
Quality Assurance, Testing
Medical device companies trust us to meet or exceed the QA standards of EMA, FDA, MHRA, and other regulatory agencies. You can navigate the procedures for medical device product review, approval, and regulatory compliance with the support of our global experience working with regulators and Notified Bodies. Read More