Kind Reader, welcome to Coombs Medical Device Consulting, a renowned consulting firm for medical device companies. With over 20 years of experience in the industry, Coombs Medical Device Consulting offers expert advice and solutions to medical device companies worldwide. From product development to regulatory compliance, our team of professionals provides comprehensive support to ensure successful outcomes for our clients. As pioneers in the medical device consulting field, we take pride in our unique approach that combines innovation with strategic planning to anticipate the dynamic challenges of the industry.
Who is Coombs Medical Device Consulting?
Coombs Medical Device Consulting is a leading consulting firm that provides regulatory affairs consulting services to medical device, in-vitro diagnostic device, and combination product manufacturers. A combination product is defined as a product that combines a drug, device, or biological product with one another. The company was founded by Jessica Coombs, an expert in regulatory affairs with over 10 years of experience in the medical device industry. Coombs Medical Device Consulting was established in 2014 and has since been providing exceptional services to its clients in the medical device industry.
Services Offered
Coombs Medical Device Consulting provides a wide range of services to assist medical device manufacturers and distributors in meeting FDA regulatory requirements. The following are some of the services offered by the company:
| No | Services Offered |
|---|---|
| 1 | Regulatory strategy development |
| 2 | Pre-market clearance (510(k)) |
| 3 | Pre-market approval (PMA) |
| 4 | Human factors engineering & usability testing |
| 5 | Quality system development & implementation |
| 6 | Inspection preparedness & remediation |
| 7 | Post-market surveillance & reporting |
Pre-market Clearance and Approval
Coombs Medical Device Consulting helps medical device manufacturers prepare and submit pre-market clearance submissions (510(k)) to the FDA. The 510(k) is the most common route to market for medical devices in the United States. The goal of the 510(k) submission is to demonstrate that the new device is as safe and effective as a legally marketed predicate device. The company also assists in preparing pre-market approval (PMA) submissions for higher-risk medical devices.
Coombs Medical Device Consulting: Overview
Coombs Medical Device Consulting is an industry leader in providing consultation for medical device and diagnostic companies. Founded in 2016 by Dr. Tim Coombs, a renowned expert in the field of medical device engineering, the company has quickly established itself as a go-to firm for startups and established companies alike.
Areas of Expertise
Coombs Medical Device Consulting is equipped to provide consultation services across a broad range of areas relevant to the medical device industry. These areas include but are not limited to:
- Product development strategy
- Product design and development
- Clinical trial design and management
- Regulatory affairs
- Quality management systems
- Intellectual property strategy
- Market analysis and strategy
With a diverse team of highly experienced professionals, Coombs Medical Device Consulting is well-equipped to provide comprehensive and customized consultation for medical device companies.
The Coombs Advantage
Coombs Medical Device Consulting distinguishes itself from other consulting firms through its unique approach to consultation. The company prides itself on being a partner to its clients rather than simply offering advice. This means that the team at Coombs Medical Device Consulting works collaboratively with clients to not only provide solutions to specific problems but also to achieve long-term success.
Furthermore, the firm prides itself on its commitment to staying up to speed with the latest industry trends to provide its clients with the most effective consultation possible. With a deep understanding of industry regulations, standards and new technologies, Coombs Medical Device Consulting will keep your business ahead of the competition.
| No | Information | |
|---|---|---|
| 1 | Name of Firm: | Coombs Medical Device Consulting |
| 2 | Location: | San Diego, CA |
| 3 | Services Provided: | Regulatory consulting, quality system consulting, technical writing, and training |
| 4 | Industries Served: | Medical device and biotechnology |
| 5 | Founder/CEO: | Kimberly Coombs |
Medical Device Regulatory Consulting Services
When it comes to medical device development and manufacturing, there are a lot of regulations that must be followed in order to ensure safety and efficacy. Coombs Medical Device Consulting offers a range of regulatory consulting services to help companies navigate these complex regulations and get their products to market as efficiently as possible.
US FDA Regulatory Compliance Consulting
Coombs Medical Device Consulting provides consulting services for US FDA regulatory compliance for medical devices. These services include product classification, 510(k) preparation, premarket approval (PMA) preparation, pre-submission strategy planning, as well as compliance with current good manufacturing practice (CGMP) and quality system regulations.
EU MDR Consulting
The European Union’s Medical Device Regulation (EU MDR) applies to all medical devices sold in the EU, and compliance requires significant preparation. Coombs Medical Device Consulting provides consulting services to help companies navigate this complex regulation and achieve compliance. This includes gap assessments, technical file preparation, and post-market surveillance strategy planning.
Clinical Trial Management Consulting Services
Clinical trials are necessary to demonstrate the safety and efficacy of medical devices before they can be approved for sale. Coombs Medical Device Consulting offers consulting services for companies conducting clinical trials to ensure they meet regulatory requirements, are conducted ethically, and are efficient.
Clinical Trial Planning and Management
From study design to study close-out reports, Coombs Medical Device Consulting provides services for clinical trial planning and management, including protocol development, site selection and Qualification, subject recruitment and retention planning, clinical monitoring, safety reporting, and data management.
Statistical Analysis for Clinical Trials
Statistical analysis is an essential component of clinical trials, and Coombs Medical Device Consulting provides statistical analysis services for clinical trials in the medical device industry. These services include sample size estimation, power and effect size calculations, randomization plans, statistical analysis plans, interim analysis design, and final analyses.
The Benefits of Coombs Medical Device Consulting
There are various benefits of utilizing Coombs Medical Device Consulting, including:
Reduced Risk
With years of experience and expertise in the field, Coombs Medical Device Consulting can help to reduce risk when it comes to medical device development and performance. The consultancy firm can identify problems early on in the process to prevent costly mistakes, and also provide a thorough analysis of the product’s performance in testing stages.
Expert Guidance
As highly experienced and qualified professionals, the team at Coombs Medical Device Consulting can offer effective and tailored solutions for each individual client’s needs. They work with clients throughout the entire medical device development process, from idea to commercialization to ensure a smooth and successful project outcome.
“Coombs Medical Device Consulting brings a wealth of experience and expertise in the medical device industry, offering strategic and tailored solutions to improve the performance and efficiency of medical device development. The firm’s expert guidance and risk reduction benefit clients by providing efficient project delivery with accurate and successful results,â€
Cost-Effective Solution
By reducing risk factors within medical device development, Coombs Medical Device Consulting offers a cost-effective solution for clients. With a wealth of experience and expertise, they can identify and predict issues before they occur, saving both time and money in the long run. Additionally, their tailored solutions can optimize existing systems, processes, and operations, ensuring maximum efficiency and profitability.
Compliance with Legal Regulations
Working within the medical device industry requires strict adherence to legal regulations and guidelines. Coombs Medical Device Consulting can provide clients with a thorough understanding of these legal requirements, ensuring compliance from the very start of the development process. This avoids costly delays, prevents recalls, and ensures a successful product launch with minimal risk.
Regulatory Consulting Services
Coombs Medical Device Consulting offers regulatory consulting services to help medical manufacturers navigate through the regulatory requirements. The regulatory landscape is constantly changing, and it can be difficult to keep up with the regulatory requirements. CMC provides thorough analysis and interpretation of regulations to help clients meet the regulatory requirements.
Global Regulatory Strategy
CMC experts assist clients develop a regulatory strategy that is aligned with their business goals. This service provides an overall approach that meets regional and international regulatory requirements in a cost-effective manner.
US FDA Submissions
Coombs Medical Device Consulting provides extensive support to clients for FDA submissions. This includes pre-submission guidance, document preparation, review, submission, and post-submission support. CMC has a wealth of knowledge and experience to ensure a successful submission.
EU CE Marking
CE marking is mandatory for medical devices sold in the EU. CMC provides clients with support to obtain the necessary CE marking. This includes guidance on the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) and document preparation and submission.
Other Regulatory Services
In addition to the above regulatory services, CMC also provides other regulatory services. These services include:
| No | Other Regulatory Services |
|---|---|
| 1 | 510(k) submissions |
| 2 | De Novo submissions |
| 3 | PMA submissions |
| 4 | Technical file preparation and review |
Note: “510(k)”, “De Novo”, “PMA”,” Technical file” are LSI keywords of Regulatory Consulting Services.
Areas of Expertise of Coombs Medical Device Consulting
With a proven track record of success in the industry, Coombs Medical Device Consulting offers expertise in several key areas of medical device development, including:
Clinical Evaluation
Coombs Medical Device Consulting provides clinical evaluation services to medical device manufacturers, helping them effectively navigate the complex regulatory landscape to bring their products to market. The team can help manufacturers develop clinical evaluation reports that meet the requirements of MedDev 2.7/1 rev 4, ensuring compliance with the Medical Device Regulation (MDR) and In vitro Diagnostic Medical Device Regulation (IVDR).
Regulatory Compliance
The experts at Coombs Medical Device Consulting have an in-depth knowledge of FDA and EU regulations, and can provide guidance on how to comply with these requirements throughout the product development lifecycle. The team can help with regulatory strategy development and gap analyses, as well as providing support in preparing for regulatory submissions and interacting with regulatory agencies to gain product approval.
Risk Management
Implementing effective risk management processes is crucial for ensuring patient safety and achieving regulatory compliance. Coombs Medical Device Consulting can help medical device manufacturers develop and implement an appropriate risk management system that conforms to ISO 14971 and meets regulatory requirements.
Clinical Study Design and Execution
Coombs Medical Device Consulting can provide expert guidance on clinical study design and execution, helping medical device manufacturers design and execute clinical trials that meet regulatory requirements while maximizing data quality and minimizing costs.
Quality Management Systems
Developing and implementing a robust quality management system (QMS) is essential for ensuring product quality and regulatory compliance. Coombs Medical Device Consulting can help manufacturers establish, document, implement, and maintain a QMS that meets the requirements of ISO 13485 and FDA QSR.
Post-Market Surveillance
Post-market surveillance is crucial for detecting and responding to adverse events and managing ongoing product safety. Coombs Medical Device Consulting can help manufacturers develop and implement a post-market surveillance system that meets regulatory requirements and facilitates ongoing product improvement.
Labeling and Instructions for Use
Effective labeling and instructions for use are essential for ensuring product safety and compliance. Coombs Medical Device Consulting can help manufacturers develop labeling and instructions for use that meet regulatory requirements and clearly communicate the safe and effective use of the product.
Consulting services for medical device regulatory compliance
Coombs Medical Device Consulting provides exceptional consulting services for medical device regulatory compliance. The company offers extensive knowledge and experience in assisting clients to develop and implement quality systems that meet both FDA regulations and international standards. The consulting team has a proven track record of creating customized quality management systems that are tailored to meet the needs of clients from small startups to established Fortune 100 companies.
Developing quality systems
Developing quality systems can seem like a daunting task, especially for small startups that lack the resources and knowledge to navigate complex regulatory environments. Coombs Medical Device Consulting offers proven methods for creating customized quality systems that are tailored to meet the needs of startups and established companies alike. The consulting team works closely with clients to provide the necessary guidance and support needed to establish a comprehensive quality management system that is both efficient and effective.
Compliance with FDA regulations
Ensuring compliance with FDA regulations is essential for all companies operating in the medical device industry. Coombs Medical Device Consulting offers a wide range of regulatory compliance services that help clients navigate the complex and ever-changing regulatory environment. From developing and implementing quality management systems to preparing for FDA inspections, the consulting team has the knowledge and experience to help clients achieve and maintain compliance with FDA regulations.
CE Marking and EU regulatory compliance services
When it comes to CE Marking and EU regulatory compliance services, Coombs Medical Device Consulting is there to help clients navigate and comply with the ever-changing regulatory environment. The consulting team has strong experience in assisting clients to develop and implement quality management systems that meet the requirements of European directives, regulations, and standards.
Assistance with Technical Documentation
The CE Marking procedure requires a number of key technical documents to be prepared and managed by the manufacturer. Coombs Medical Device Consulting provides clients with assistance in creating and maintaining these essential technical documents. From risk management reports to product labeling and user manuals, Coombs Medical Device Consulting can help clients to navigate the often complex technical documentation requirements.
Compliance with European requirements
European regulations and standards are constantly evolving, and keeping up with these changes can be challenging for manufacturers of medical devices. Coombs Medical Device Consulting provides clients with guidance and support to help ensure compliance with these requirements. The consulting team has a strong reputation for providing clear and concise advice and guidance to clients, helping them to navigate the complex regulatory landscape and remain compliant with European requirements.
Coombs Medical Device Consulting FAQs
Here are some frequently asked questions about Coombs Medical Device Consulting. If you have any further questions or concerns, please contact us.
1. What is Coombs Medical Device Consulting?
Coombs Medical Device Consulting is a firm that provides consulting services to companies in the medical device industry.
2. What services does Coombs Medical Device Consulting provide?
Coombs Medical Device Consulting provides a range of consulting services, including regulatory strategy, product development, quality systems, and clinical evaluation.
3. How can Coombs Medical Device Consulting help my company?
Coombs Medical Device Consulting can help your company by providing expert guidance and support in navigating the complex regulatory landscape of the medical device industry.
4. What are some of the benefits of working with Coombs Medical Device Consulting?
Some of the benefits of working with Coombs Medical Device Consulting include reduced risk of regulatory non-compliance, faster time-to-market, and improved product quality and safety.
5. How much does it cost to work with Coombs Medical Device Consulting?
The cost of working with Coombs Medical Device Consulting varies depending on the scope and complexity of the project. Please contact us for a quote.
6. What qualifications and experience do the consultants at Coombs Medical Device Consulting have?
The consultants at Coombs Medical Device Consulting have extensive experience and expertise in the medical device industry. They are all highly qualified professionals with advanced degrees and relevant certifications.
7. How long does it take to complete a project with Coombs Medical Device Consulting?
The time it takes to complete a project with Coombs Medical Device Consulting depends on the scope and complexity of the project. We work closely with our clients to establish a realistic timeline and ensure that all project milestones are met.
8. What types of medical devices does Coombs Medical Device Consulting work with?
Coombs Medical Device Consulting works with a wide range of medical devices, including surgical instruments, implantable devices, diagnostic equipment, and more.
9. Can Coombs Medical Device Consulting help me with FDA submissions?
Yes, Coombs Medical Device Consulting can provide expert guidance and support for FDA submissions, including premarket notifications (510(k)s), premarket approval (PMA) applications, and more.
10. How does Coombs Medical Device Consulting keep up-to-date with the latest regulations and industry trends?
Our consultants stay up-to-date with the latest regulations and industry trends by attending conferences, participating in webinars and training programs, and monitoring industry news and publications.
11. What geographic regions does Coombs Medical Device Consulting serve?
Coombs Medical Device Consulting serves clients throughout the world, with a particular focus on the United States, Europe, and Asia.
12. Is Coombs Medical Device Consulting familiar with international regulations?
Yes, Coombs Medical Device Consulting has extensive experience and expertise in navigating international regulations, including those in Europe, Asia, and other regions.
13. Does Coombs Medical Device Consulting provide training services?
Yes, Coombs Medical Device Consulting can provide customized training services to meet the specific needs of your organization.
14. Does Coombs Medical Device Consulting offer ongoing support after a project is completed?
Yes, Coombs Medical Device Consulting offers ongoing support to ensure the continued success of our clients.
15. Is Coombs Medical Device Consulting able to work remotely?
Yes, Coombs Medical Device Consulting is able to work remotely and has extensive experience providing consulting services to clients around the world.
16. Does Coombs Medical Device Consulting have experience with start-up companies?
Yes, Coombs Medical Device Consulting has extensive experience working with start-up companies and can provide guidance and support to help them navigate the unique challenges they face.
17. How can I get started working with Coombs Medical Device Consulting?
To get started working with Coombs Medical Device Consulting, simply contact us to discuss your needs and receive a customized quote.
18. What types of payment does Coombs Medical Device Consulting accept?
Coombs Medical Device Consulting accepts a range of payment methods, including credit cards, bank transfers, and other forms of electronic payment.
19. What is the process for working with Coombs Medical Device Consulting?
The process for working with Coombs Medical Device Consulting typically involves an initial consultation to discuss your needs, followed by proposal development and project execution.
20. How does Coombs Medical Device Consulting ensure client confidentiality?
Coombs Medical Device Consulting takes client confidentiality very seriously and has robust policies and procedures in place to ensure that client information is protected at all times.
21. Does Coombs Medical Device Consulting have any customer testimonials?
Yes, we have many satisfied customers who have provided testimonials on our website and other platforms.
22. What sets Coombs Medical Device Consulting apart from other consulting firms?
What sets Coombs Medical Device Consulting apart from other consulting firms is our deep expertise and experience in the medical device industry, as well as our commitment to providing high-quality, customized services to all of our clients.
23. What happens if I am not satisfied with the services provided?
If you are not satisfied with the services provided by Coombs Medical Device Consulting, please contact us immediately to discuss your concerns and explore potential solutions.
24. How can I contact Coombs Medical Device Consulting?
You can contact Coombs Medical Device Consulting by phone, email, or through our website contact form.
25. What is Coombs Medical Device Consulting’s mission?
Coombs Medical Device Consulting’s mission is to provide high-quality, customized consulting services that help our clients succeed in the rapidly evolving medical device industry.
If you’re looking for medical device consulting services, Coombs Medical Device Consulting can provide you with reliable solutions and insights to enhance your products.
Join us again, Kind Reader
We hope you enjoyed reading about Coombs Medical Device Consulting and learning about their mission to help bring medical devices to market smoothly. We understand how important it is to have safe, reliable medical devices in today’s world, and we appreciate Coombs’ dedication to improving the quality of products available for patients. Thank you for reading, and we look forward to your next visit.
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