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
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.
With 20 years of international business experience I have approached and navigated many business & technical issues and can help you navigate your current situation.
I have a set of trained developers across various tech stacks who can jump on your project and comply with your QMS.
Contact me for a free discussion about your project and how I can help.
Reach out to us today and get a complimentary consultation.