Full Lengthen Video | Regulatory Affairs | Runtime 3:02 mins
Submission Strategy
Testing Strategy
510(k) / Technical File Creation
FDA / Notified Body Communication
Compliance Assurance
Regulatory File Submission
Whether a 510(k) in the US or a technical file in the EU, we will compile and submit all the necessary documents
We consider the best strategy for the highest chance of a successful submission, giving you confidence of clearance as quickly as possible
With our assistance in communications with the regulatory body, you place trust in experts with decades of experience and sharpness of recent changes
Whether a 510(k) in the US or a technical file in the EU, we will compile and submit all the necessary documents
We consider the best strategy for the highest chance of a successful submission, giving you confidence of clearance as quickly as possible
With our assistance in communications with the regulatory body, you place trust in experts with decades of experience and sharpness of recent changes
View Our Process: The New Product Development (NPD) Roadmap:
Download this step-by-step guide illustrating each phase of our new product development (NPD) process and how all of our services integrate.
On-going Resource
Our expert resources will act as your regulatory representative whether precommercialization or post market
The Regulatory representative can integrate into a new product development process that Kapstone is doing or seamlessly plug in to your team.
Our expert resources will act as your regulatory representative whether precommercialization or post market
The Regulatory representative can integrate into a new product development process that Kapstone is doing or seamlessly plug in to your team.
Regulatory Consultant
MDR Training:
The EU’s decision to replace the Medical Devices Directive (MDD) with the Medical Device Regulation (MDR) has had major implications on the industry. With the vast amount of publications by the legislation and by third parties, many companies are unsure of how this affects them. With our practical experience in the EU, Kapstone can get straight to what is needed for your organization and customize an action plan for each department.
MDR Training:
The EU’s decision to replace the Medical Devices Directive (MDD) with the Medical Device Regulation (MDR) has had major implications on the industry. With the vast amount of publications by the legislation and by third parties, many companies are unsure of how this affects them. With our practical experience in the EU, Kapstone can get straight to what is needed for your organization and customize an action plan for each department.
FDA Training:
From learning how to register with the FDA to being compliant with quality system regulations (QSR) to understanding product codes and device classification, Kapstone can guide and equip your organization.
FDA Training:
From learning how to register with the FDA to being compliant with quality system regulations (QSR) to understanding product codes and device classification, Kapstone can guide and equip your organization.
Remediation:
Changing regulatory requirements, complexity in large organizations, and acquiring other companies or technologies are all common reasons for why medical device companies get behind in regulatory requirements. Kapstone understands these dynamics and will assist in getting you compliant by assessing your situation, devising an appropriate action plan, and executing efficiently with your team.
Remediation:
Changing regulatory requirements, complexity in large organizations, and acquiring other companies or technologies are all common reasons for why medical device companies get behind in regulatory requirements. Kapstone understands these dynamics and will assist in getting you compliant by assessing your situation, devising an appropriate action plan, and executing efficiently with your team.
US FDA Agent:
For foreign companies looking to sell in the US market and therefore needing a US FDA Agent, Kapstone will not only fill that requirement but communicate with the FDA with your interested in mind. As an experienced regulatory consultant, you can trust us to assist with important regulatory information such as compliance issues, product related problems, or inspection schedules.
US FDA Agent:
For foreign companies looking to sell in the US market and therefore needing a US FDA Agent, Kapstone will not only fill that requirement but communicate with the FDA with your interested in mind. As an experienced regulatory consultant, you can trust us to assist with important regulatory information such as compliance issues, product related problems, or inspection schedules.
Your ISO 10993 Guide: Understand and Safely Navigate Biocompatibility Standards
Successfully bring your device to market in a safe, cost effective way by:
- Understanding the requirement of ISO 10993
- Learn which type of devices are under the most scrutiny
- Gaining a better understanding of the costs & time required for certain biocompatibility testing
- Follow one example case study
