Turn Your Medical Data
into a Medical Device

Make your SaMD project a Success

Richard Koch

I help you with your Software as a Medical Device (SaMD) Project.

The skill set for SaMD is broad and requires accuracy to deliver your product on time and in-scope. I can help you with a range of services to support you in your SaMD ambition and offer you my experience & knowledge in making your project a success.

This includes helping you implement SaMD compliant Agile processes, gain new or updated ISO13485 certifications with SaMD scope, manage your SaMD development team, implement ISO14971 compliant risk management verification & validation systems, guide you on your SaMD product roadmap & strategy, amongst a range of other services.

I also have a team of IEC62304 trained developers across a range of technologies who can jump on to your project & follow your own QMS processes to deliver high quality & compliant code.

Feel free to email me or book a time to talk about your needs.

I look forward to talking.

Richard

Wide Knowledge

There are hundreds of pages of International & Regulatory standards to navigate in an SaMD project. Work with someone who can guide you through this maz.

Solid experience

With 20 years of international business experience I have approached and navigated many business & technical issues and can help you navigate your current situation.

Professional team

I have a set of trained developers across various tech stacks who can jump on your project and comply with your QMS.

My services

Product planning

You have an idea and want to bring it to reality. Let's talk about how your development, regulatory and commercial path work together to deliver your product.

Project Management

Need your project managed? I can manage your entire project as a product manager, or get into the detail to deploy sprints. Let's talk.

SaMD ISO13485 Certification

Need a new or upgraded ISO13485 ceritficate with SaMD scope? Let's talk about how I can help you implement IEC62304 compliant procedures based on Agile tools & methodologies.

IEC62304 Deployment

Need help upgrading your new or existing Requirements to Release and Defect to Resolution processes to become IEC62304 compliant? Let's talk.

SaMD Risk Management

It is only data right? How risky can it be? Let's talk abour your ISO14971 Risk Management Plan & integrated Verification and Validaiton planning and execution to help you manage clinical and non-clinical risks.

Turn Your Medical Data
into a Medical Device