Our services

The FDA environment for medical devices and combination devices has become more challenging than ever. Developing a detailed strategy and tactical implementation plan is key in bringing products to market in a timely fashion. It is critical to understand how all parts of the product development and submission process interact together and how to proceed to quickly bring a new product to market. YDE Biomed Consulting contribution does not end with FDA approval as we continue to support your in-house capabilities in developing their expertise to maintain regulatory compliance and in implementing manufacturing and product improvements.

Outlining a strategy starts during the product development and design control process to outline which preclinical testing is necessary to support a submission. It includes understanding FDA requirements in a forever changing environment. During project planning, in coordination with all stakeholders, we will identify potential risks and how to mitigate them to ensure a successful execution of the strategic plan. We are committed in developing a winning regulatory and clinical strategy for your business that is realistic and effective.

YDE Biomed Consulting offer expertise in a wide range of medical devices (or combination devices) in aesthetics, orthopedics, cardiovascular, cardiopulmonary, dental, obesity, surgical, in-vitro diagnostics, wound care and diabetes. We work with start-ups to well establish U.S. or international companies. We keep our expertise on top of all recent regulatory developments for long term implantable, for combination devices and for medical devices containing software with virtual or augmented reality.

Being in an FDA-regulated industry may sometimes feel overly complex, challenging and frustrating. To be a successful business, not only you have to develop a new, innovative, effective and safe product but you must also successfully navigate all the regulatory requirements before being able to receive approval and commercialize your device.

——> Regulatory and Clinical Affairs are at the core competency of YDE Biomed Consulting.

We have been trusted and have in depth experience of a broad range of regulatory activities:
• Pre-Submission package and meeting with FDA (QSub)
• 513(g) request for product classification
• Request for Designation for combination device
• 510(k) or De Novo 510(k) submission
• PMA (modular or not) and PMA supplements submission
• Responses to deficiency letter
• Labeling updates
• Recall management
• Interactive communications with FDA
• Regulatory due diligence
• Regulatory gap assessment

We are proud to have developed long term partnerships with our clients from across the world.

YDE Biomed Consulting will bring insight and its extensive experience to assist you successfully enter and obtain market approval in the United States.

Getting your new product approve may require compelling clinical evidence. We understand all the phases of clinical research from first-in-human to pivotal and post-market studies.

YDE Biomed Consulting will provide expert planning, management and preparation of clinical studies to bring your product to market or post-approval.

We have extensive experience in all the clinical study stages from design to close-out:
• Pre-Submission package and meeting with FDA (QSub)
• IDE submission to FDA and interactions with FDA
• IDE periodic progress reports to FDA
• Clinical design synopsis and protocol development
• Clinical Investigation Protocol and Report review
• Close coordination with your CRO for the development of clinical trial documentation

YDE Biomed Consulting will be your long term partner to ensure that your clinical data will support your overall regulatory strategy and future market approval.

YDE Biomed Consulting integrated services and offerings are custom-designed to assist you accelerate achieve regulatory approval and market introduction.

We can be your official correspondent and the direct point of contact of the Agency or be in the background of all your communications with FDA. We will provide hindsight and expertise to give you the confidence that your exchanges with FDA are effective and will support your ultimate goal: APPROVAL.

We will give you input to identify which topic may or may not be negotiable, how to best approach and present your argument and how to best utilize all channels of communication. We will assist you in establishing a trusted relationship with FDA as one of the founding block for all your regulatory submissions.

Unsure that your quality system is GMP compliant? Your company is already ISO 13485 certified and in need of breaching the gap to be GMP compliant?

-> We can perform a gap analysis of your Quality System, develop an action plan to achieve compliance or stay focus and optimize only some aspects of your quality system such as Design Control, Supplier Quality or Change Management.

Need to be sure you are ready for your next FDA audit?

——> Experienced compliance auditors from YDE Biomed Consulting will come on site and perform a mock FDA audit and train your staff about what to expect.

We can help you with all administrative aspects of FDA submissions and registration. During any of your submissions, we can act as your Official Correspondent.
• If your business gross receipt and sales is less than $100 million for the most recent tax year, we will assist you to be recognized as a Small Business by FDA in order to pay reduced fees for your submission.
• We will also assist you for your initial and annual establishment registration and device listing.
• If you are a foreign establishment, we can also act as your U.S. Agent.

People are your best assets. We understand that your internal resources may not have the bandwidth or expertise (yet) for all your regulatory or clinical submissions.

While working with your team, we will transfer knowledge to allow your company become more self-reliant and stronger for its future. We see our mission not only to provide ad-hoc assistance for your submission and receive FDA approval, but also to help your people grow to be more productive and effective.

We can also customize a training program and materials to address some specific topics or reach a larger audience: GMP training, how to prepare a 510k, how to maintain regulatory compliance after a PMA etc.. Training may be in a classroom environment, remotely or on a 1:1 basis to enhance your people professional skills. Enhancing your internal talent is key to gaining long term competitive advantage.

Your company recently received 483 observations, a FDA warning letter, a long list of deficiencies or is under consent decree? Did you have to do a product recall?

These can be overwhelming, confusing and challenging times.

——> We have experience and depth of knowledge to partner with you to develop and implement a comprehensive corrective action plan to address all clinical and regulatory unexpected challenges. Every situation is different, and the action plan may include aggressive but realistic milestones, supporting tasks and task dependencies. We will be by your side with solutions until you have achieved compliance and have come out on the other side.