Software as a medical device (SaMD)
Introduction
Our client designs and sells a CE marked Class IIa software, used in cardiology as a digital twin.
Types
- Regulatory affairs
- Responsible person
- FSP
Scope of work
Our client recently partnered with groups of clinics in the United Kingdom and therefore asked us to act as their UK Responsible Person. In less than 5 days, our consultant reviewed all documentation, uploaded the requested information on the MHRA portal, and received approval from MHRA. Apotech also delivered training on how to register with the MORE portal.
Key numbers
Team
1 QARA Consultant
Location
UK
Length
3 year
Type
UKRP Service
Excited to work together on your next project?
Global in-country regulatory support
510(k) Submission Introduction Top 3 Global CRO Our client is one of the largest CROs globally, with operations present in every economy. Their services range f...
Find out more
QMS Implementation for Class III Medical Device
QMS Implementation for Class III Medical Device Introduction Streamlining ISO 13485 Certification for a connected medical device. The company is a highly innova...
Find out more
Breakthrough Program
Breakthrough Program Introduction IVD manufacturer The company is a highly innovative IVD manufacturer start-up. Their device is CE marked and the client was lo...
Find out more
Regulatory Strategy IVDR / FDA
Regulatory Strategy IVDR / FDA Introduction Deciphex Deciphex is a digital pathology workflow and integrated AI platform for research pathology, CROs and pharma...
Find out more
EU-IVDR Technical File Remediation
EU-IVDR Technical File Remediation Introduction In Vitro Diagnostic Manufacturer Our client is a leader in high-quality, innovative diagnostic products for the ...
Find out more
Software as a medical device (SaMD)
Software as a medical device (SaMD) Introduction Our client designs and sells a CE marked Class IIa software, used in cardiology as a digital twin. Types Regula...
Find out more
Process and Test Method Validation Review and Improvement
Process and Test Method Validation Review and Improvement Introduction Cardiac Devices Our client is a leading manufacturer of Class III minimally invasive card...
Find out more
Quarterly Internal Audits
Quarterly Internal Audits Introduction Quarterly Internal Audits Our client is a start-up medical device manufacturer of a body cooling device, for those with h...
Find out more
Prosthesis manufacturer
Prosthesis manufacturer Introduction Global API Manufacturer As part of their international development strategy, our client wanted to get MDSAP certified with ...
Find out more
Streamlining ISO 13485 Certification for a connected medical device
Streamlining ISO 13485 Certification for a connected medical device Introduction Our client is a startup at the forefront of connected health technology (diabet...
Find out more