SERVICES
Below are some examples of our services. Contact us to discuss your specific needs and how we can best assist.
PRODUCT DEVELOPMENT
Design Control
Design Control is the framework for how your organization develops new products. It represents the process (and procedures) used to control and monitor design activities. These controls help your organization ensure that your product(s) meet specified design requirements and that necessary compliance activities are consistently and efficiently completed during development.
Sullivan Cole will collaborate with your organization to establish a 21 CFR §820.30 / ISO 13485 compliant Design Control process. If you have Design Control in place, Sullivan Cole will audit the existing process and procedures, identify any gaps and work with you to develop a plan to address them. With experience across multiple organizations and products Sullivan Cole can provide guidance on best-in-class approach and make recommendations for enhancements and improvements to raise your processes to the next level.
Design Control is the framework for how your organization develops new products. It represents the process (and procedures) used to control and monitor design activities. These controls help your organization ensure that your product(s) meet specified design requirements and that necessary compliance activities are consistently and efficiently completed during development.
Sullivan Cole will collaborate with your organization to establish a 21 CFR §820.30 / ISO 13485 compliant Design Control process. If you have Design Control in place, Sullivan Cole will audit the existing process and procedures, identify any gaps and work with you to develop a plan to address them. With experience across multiple organizations and products Sullivan Cole can provide guidance on best-in-class approach and make recommendations for enhancements and improvements to raise your processes to the next level.
Regulatory
Understanding the regulatory requirements to market, sell, and distribute your specific product is a critical early phase element of your product development. Developing a comprehensive regulatory strategy is the first step. Sullivan Cole will partner with your organization to lay out a complete and optimized plan for your product(s) regulatory clearance. Asking all the necessary questions to ensure that your organization's plan delivers the outcome you need, while seamlessly integrating with your larger Product Development effort.
Engaging with the appropriate regulatory agencies at the right time and in the correct way will be essential to achieving the result you want and avoiding pitfalls downstream.
Let Sullivan Cole assist you with this critical element.
QUALITY MANAGEMENT
Quality Systems
In the United States, the Food and Drug Administration (FDA) is responsible for ensuring compliance with the regulation that defines quality system requirements, Federal Regulation 21 CFR Part 820 Quality System Regulation (QSR). The International Organization for Standardization (ISO) has also developed a quality management system standard for medical device companies, ISO 13485. Outside of the US compliance to ISO 13485 is required by many countries and therefore a standard which most medical device companies also need to meet.
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Sullivan Cole will assist organizations in development of a Quality Management System (QMS) that is compliant with 21 CFR §820 and ISO 13485. Sullivan Cole provides audit and gap analysis services to help organizations understand how their existing quality system compares to the required standards and shore up any gaps or deficiencies.
Design Control is the framework for how your organization develops new products. It represents the process (and procedures) used to control and monitor design activities. These controls help your organization ensure that your product(s) meet specified design requirements and that necessary compliance activities are consistently and efficiently completed during development.
Sullivan Cole will collaborate with your organization to establish a 21 CFR §820.30 / ISO 13485 compliant Design Control process. If you have Design Control in place, Sullivan Cole will audit the existing process and procedures, identify any gaps and work with you to develop a plan to address them. With experience across multiple organizations and products Sullivan Cole can provide guidance on best-in-class approach and make recommendations for enhancements and improvements to raise your processes to the next level.
Defining your organizations documentation structure is an essential building block of your Quality Management System (QMS) setup. Regulatory agencies do not prescribe the required document structure, although as industry has evolved best practices have emerged that most organizations follow.
Procedures are the backbone of your Quality Management System (QMS). They provide written documentation of the processes that govern your operation and how you intend to meet the Quality System requirements.
Sullivan Cole recommends establishing a Quality Manual as a first step to outline your organization's approach and commitment to Quality, while summarizing, among other items, how documentation will be established. From there we will advise you on priority and content in a phased approach appropriate for your organization's needs.
Documentation
PROCESS ENGINEERING
Manufacturing
Translating your product design into manufacturing requires close collaboration between your development and manufacturing resources. Ideally the collaboration starts early in the development effort, but no matter when you begin a deep understanding of GMP/GLP principles and application is essential. Sullivan Cole has significant experience with the requirements for manufacturers of medical devices and implementing these requirements within a diverse set of manufacturing conditions and environments.
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Current good manufacturing practice (cGMP) requirements govern the methods used in and the facilities and controls used for the manufacture, packaging, labeling, storage, installation and servicing of product. All of which need to be considered in your manufacturing operation.
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Whether you are just beginning your manufacturing journey or you have been manufacturing for years, Sullivan Cole can help you maintain compliance while improving efficiencies and productivity.
Design Control is the framework for how your organization develops new products. It represents the process (and procedures) used to control and monitor design activities. These controls help your organization ensure that your product(s) meet specified design requirements and that necessary compliance activities are consistently and efficiently completed during development.
Sullivan Cole will collaborate with your organization to establish a 21 CFR §820.30 / ISO 13485 compliant Design Control process. If you have Design Control in place, Sullivan Cole will audit the existing process and procedures, identify any gaps and work with you to develop a plan to address them. With experience across multiple organizations and products Sullivan Cole can provide guidance on best-in-class approach and make recommendations for enhancements and improvements to raise your processes to the next level.
Within FDA’s Quality System Regulation, validation is applicable to the product (Design Validation), the steps used to manufacture the product (Process and Cleaning Validation) and in many cases the tools and systems used within both (Software Validation, 21 CFR Part 11). Understanding the requirements for validation and navigating how to approach and successfully complete validation can be challenging.
Sullivan Cole has experience with all types of validation, including expertise in process validation (which is intended to ensure that the processes used to produce a product can consistently deliver product that meet its predetermined specifications). Sullivan Cole will assist with validation planning, protocol and test case writing, evaluation of results and deviations, as well as final report writing and approval.
Validation