Propelling products throughout the lifecycle:
2t assists you with the insight to make smart decisions about your product from development to market.
2t Medical Systems, Inc. Consultants provides a broad range of regulatory consulting, engineering consulting, and regulatory department training services to meet your needs. Although we focus on orthopedic and general hospital devices, our education, experience, and broad knowledge of FDA's processes and requirements have proven valuable for manufacturers of medical devices intended for various medical specialty areas. Whether large or small, numerous companies have found our services invaluable to their medical device development and regulatory strategy processes.
-Regulatory Consulting Services
2t Medical Systems, Inc. Consultants can help you with your medical device regulatory needs. Knowing and interpreting regulations and guidelines, and having the right strategy, the right data, and the right presentation is important for expeditious review and FDA approval of your medical device. The following are some of the key regulatory consulting services we provide. In addition, we would be happy to discuss any of your specific regulatory needs.
- Develop regulatory strategy for medical device development, pre-market submissions, and FDA review.
- Provide interpretation of applicable medical device regulations and guidance document requirements.
- Assist with preparation and provide pre-submission review of pre-market notification [510(k)], investigational device exemption (IDE), pre-market approval (PMA), and humanitarian device exemption (HDE) applications.
- Assist with product labeling and Instructions for Use (IFU) development and provide pre-submission review to ensure regulatory requirements are met.
- Initiate, coordinate, and participate in meetings with FDA to discuss regulatory, scientific, and or technical issues.
- Assist with medical device import and export requirements.
- Assist with registration, listing, and reporting requirements.
-Engineering Consulting Services
2t Medical Systems, Inc. Consultants can help you with your medical device design and testing needs. Identifying design flaws early and performing the right testing saves time and money. The following are some of the key engineering consulting services we provide. In addition, we would be happy to discuss any of your specific engineering needs.
- Perform medical device design review.
- Assist with and/or develop pre-market testing strategies and test methods.
- Assist with device failure analyses and the development and implementation of corrective action solutions.
In addition, we have formal and informal strategic alliances with several companies experienced in the design, testing, and engineering analysis of medical devices, so we can refer you to appropriate sources that can reliably provide services to fill your specific needs.
-Regulatory Training & Consulting Services
2t Medical Systems, Inc. Consultants can help you with your medical device regulatory needs. Knowing and interpreting regulations and guidelines, and having the right strategy, the right data, and the right presentation is important for expeditious review and FDA approval of your medical device. The following are some of the key regulatory consulting services we provide. In addition, we would be happy to discuss any of your specific regulatory needs.
- Develop regulatory strategy for medical device development, pre-market submissions, and FDA review.
- Provide interpretation of applicable medical device regulations and guidance document requirements.
- Assist with preparation and provide pre-submission review of pre-market notification [510(k)], investigational device exemption (IDE), pre-market approval (PMA), and humanitarian device exemption (HDE) applications.
- Assist with product labeling and Instructions for Use (IFU) development and provide pre-submission review to ensure regulatory requirements are met.
- Initiate, coordinate, and participate in meetings with FDA to discuss regulatory, scientific, and or technical issues.
- Assist with medical device import and export requirements.
- Assist with registration, listing, and reporting requirements.
-Regulatory Training & Support Services
2t Medical Systems, Inc. Consultants can help train and support your staff. Having well-trained and knowledgeable individuals will create a seamless blend of your regulatory, marketing, and technical departments. The following are some of the key regulatory seminars we can provide your staff. In addition, we would be happy to discuss any of your specific training needs.
- FDA History and the Food, Drug, and Cosmetic Act
- FDA Laws and Regulations
- FDA Organization, Structure, and Function
- CDRH Goals, Initiatives, and Programs
- FDA Medical Device Regulations
- Pre-Market Submissions and Requirements
- Investigational Device Submissions and Requirements
- Medical Device Labeling Requirements
-Quality Assurance Consulting Services
2t Medical Systems, Inc. Designing and implementing quality systems and manufacturing programs saves time and money. Efficiently analyzing and correcting flawed quality systems programs helps reintroduce products to the market and/or helps keep products on the market.
2t Medical Systems, Inc. Device Consultants can help you meet your quality assurance requirements. The following are some of the key QA consulting services we provide. In addition, we would be happy to discuss any of your specific QA needs.
- Analyze, design, and implement programs to meet GMP/ISO requirements.
- Assist with obtaining GMP/ISO certifications.
- Review and/or prepare manufacturing/QA system sections of regulatory submissions.
- Conduct pre-FDA inspection audits and mock inspections.
- Provide QA/QRS training.
