Regulatory Affairs

Full Lengthen Video | Regulatory Affairs | Runtime 3:02 mins

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Submission Strategy
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Testing Strategy
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510(k) / Technical File Creation
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FDA / Notified Body Communication
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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

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.