Regulatory Solutions

Medical Devices

Strategic Regulatory Pathway to Success

CSSi LifeSciences has extensive knowledge and decades of experience in developing medical devices and bringing them to market. Our team has successfully guided novel medical device technologies through the complicated and complex FDA approval process. Our approach is designed to overcome regulatory hurdles and minimize product development time, risk, and cost.

We are experts in successfully navigating the health authority and regulatory landscape for medical devices and have done so in numerous countries. Our team has obtained clearance for over 250 medical device technologies.

 

medical devices

We help clients unlock value by engaging effectively with regulatory health authorities through regulatory plans that support your FDA communications and align with your product development milestones.

Each year we prepare a wide variety of agency submissions for medical devices. Get both the expertise and the solutions you need from a dedicated, successful team who knows how to navigate the FDA’s regulatory and oversight processes.

Our goal is to develop strategies that align with our clients’ interests so that they may remain focused on what they do best: innovating and developing the next generation of successful therapeutics.

Our Unique Approach

With CSSi LifeSciences, It’s as Easy as One, Two, Three

The number one in a purple circle

We help you unlock value by engaging effectively with regulatory health authorities through regulatory plans that support and align with your product development milestones.

The number two in a purple circle

We provide a customized regulatory solution and the support of a dedicated team throughout the life of the project based on your needs and stage of development.

The number three in a purple circle

Our staff helps you navigate the complex and evolving regulatory environment during both preclinical and clinical stages to facilitate successful and timely agency interactions.

Regulatory Consulting and Management

We provide customized regulatory affairs services for global markets and support the full product lifecycle, including:

  • Design and engineering consultation
  • Regulatory consulting and project management
  • Defining regulatory requirements and recommendations for new products
  • Target Product Profile
  • Gap assessments
  • Predicate assessment
  • FDA Special Designations (i.e., Breakthrough)
  • Human Factors testing
  • Label development and negotiation
  • Hazard assessment
  • Feasibility risk assessment
  • Advertising and promotional material review
  • Clinical studies and management

Regulatory Planning and Gap Assessment

Defining your goals and creating a strategic roadmap to help you achieve them in a manner that mitigates time, risk, and costs are critical to success. Often it is the strategy and not the medical device that fails.

CSSi LifeSciences has the strategic insight and experience to provide the complex solutions that accelerate drugs from discovery to commercialization. We offer clients a head start through our deep understanding of the expectations and guidance required to achieve success at each milestone during the development of a new medical device.

This includes a thorough assessment of your design files, existing data, prior regulatory filings, and the latest FDA guidances.

We provide customized regulatory solutions and a dedicated team based on your needs and stage of development. Our staff helps you navigate the complex and evolving regulatory environment to facilitate successful and timely Agency interactions.

Health Authority Interactions and Meetings

CSSi LifeSciences has extensive experience in the conduct and management of U.S. FDA and global health authority meetings and formal communications which ensure that you achieve the guidance and clarity needed to successfully execute your regulatory and clinical development program and establish a basis for approval.

Our experience includes:

  • FDA meetings (i.e., Pre-Submission, Q-Sub)
  • Responses to Health Authority questions and requests for additional information
  • Representation with FDA and National Competent Authorities
  • Scientific Advice (EMEA) meeting preparation and argument development

An FDA Pre-Sub (or Q-Sub) provides the opportunity for sponsors to obtain FDA feedback prior to an intended premarket submission (i.e., IDE, PMA, HDE, De Novo request, 510(k), Dual, BLA, IND). A Pre-Sub meeting request should include specific questions regarding review issues relevant to a planned IDE, CW, or marketing submission (e.g., questions regarding cybersecurity considerations for the device; non-clinical testing protocols; design and performance of clinical studies and acceptance criteria). A Pre-Sub is appropriate when the FDA’s feedback on specific questions is necessary to guide product development and/or submission preparation.

CSSi LifeSciences has extensive experience and can provide you with best practices for a successful FDA meeting.

Regulatory Solutions for Medical Devices

Submissions & Communications

The CSSi LifeSciences Regulatory Team has demonstrated tremendous success in completing a wide variety of submissions to health authorities in the U.S. and abroad. Our record speaks for itself. Our staff understands the guidances and the FDA “speak” required to successfully guide a new submission to the U.S. market. We are experts in creating documentation that addresses FDA requirements and minimizes the need for clarifications and follow-up questions. 

Our integrative process provides a 360-degree assessment to achieve positive results for even the most challenging and complex submissions.

We lead and collaborate with teams to strategize, develop, write, edit, review, and submit all required FDA technical documents and submissions. From the U.S. FDA CDRH Pre-Submission Meeting Request, as well as a host of others, our team of regulatory experts will be your trusted partners through the submission process, including:

  • Class 1, 2 and 3 applications (e.g., 510(k), De Novo, PMA)

  • 513(g) request designations

  • Pre-Market Authorizations

  • CE Mark

  • Device Master Files

  • Label and package leaflets, and user testing for readability

  • Global expansion: filing support documents for ROW submission

Supporting Services
Manufacturer Registration

CSSi LifeSciences is trusted by some of the world’s leading device manufacturers to successfully complete and manage all annual registration and regulatory requirements for medical device manufacturers operating in the U.S., and to facilitate the inclusion of approved devices on the FDA’s device listings website. CSSi LifeSciences also has the knowledge and expertise to serve as a U.S. Agent to represent your company’s interests before the FDA.

Integrated Project Management

CSSi LifeSciences provides all the relevant consulting and embedded management capabilities required to support the development of a medical device from discovery to commercialization. We offer partial or fully integrated solutions to meet your needs by blending deep subject matter expertise with many years of technical and project management experience. Our approach is based on understanding your unique needs and challenges and crafting an integrated development plan to meet them.

On-Demand Development Team—A Proven, Flexible Model

The design and development of a medical device requires numerous experts from diverse fields working together during product development. Unfortunately, assembling an expert team can be prohibitively expensive for small companies who are forced to bring in individual consultants as the needs arise. This approach typically leads to disjointed tasks not aligned with the product strategy, or a development strategy that does not consider the numerous phases that are appropriate for the stage of development. Therefore, many virtual and emerging medical device companies are looking for the help and experience only an accomplished drug CRO and consulting group can provide.

CSSi LifeSciences has a dedicated team ready to help you accelerate your product to commercialization. Our consultative, problem-solving approach is based on first understanding your unique challenges and then crafting a milestone based and flexible plan to achieve your goals. We utilize a stepwise approach for drug development that is appropriate to the phase of development.

Project Management

  • Project planning and development
  • Vendor sourcing and management
  • Out-sourced staffing
Design and Product Development

From a “back of napkin” concept to final commercial product release, CSSi LifeSciences has the experience and expertise to help clients successfully design, test, and develop a novel medical device product. Innovative medical device design requires inspiration that creates market differentiation and competitive advantages.

Our team can optimize your design development process to keep expenses low and minimize the total duration of the project and maximize your return on investment. We can work with you to design and to document your device files to meet the FDA requirements.

Our services use a client-specific mixture of research methods to build a solid foundation for design with an eye to the future. Every innovation challenge is different.

We can provide:

  • Quantitative and qualitative research
  • Validation research
  • Journey and ecosystem mapping
  • Competitive analysis
  • Business model scenarios
  • Design and engineering consultation
  • Design file management
  • Vendor sourcing
  • Software and human factors
  • Hazards risk assessment
  • Software failure modes and effects analysis (FMEA)
Analytic and Testing Management

Medical device companies must ensure the safety of patients and device users. Thus, comprehensive testing is required throughout the development process. Our medical device validation services are developed in a way to ensure that the device works as it should in the field. Our team will work with you to help define the requirements necessary for FDA approval. We combine our extensive medical device industry background and our world-class technical capabilities to help you achieve your goals – from submissions to market release.

Risk Management Assessment

From design, to engineering, to testing, and beyond, your medical device risk management process is an integral part of every phase of the project. Whether you are seeking to design a new product or improve an existing one, your medical device risk management process must be rigorous, especially if you are trying to gain FDA & CE approval.

If your medical device risk management process is not done correctly, your project may lack certain mitigations. This not only affects your budget and increases time to market, but if found late in the process you may be required to redesign, redevelop, and retest your device, throwing your project off the rails.

CSSi LifeSciences can ensure that your device meets the proper requirements so the FDA approval process goes smoothly.

CSSi LifeSciences has the experience and knowledge to create a balanced risk management process.

Simplify the regulatory process for your medical device with our management & strategy support