đź‘‹ Kristoffer Madsen here
DM: https://www.linkedin.com/in/kristoffer-madsen-34144843/
I am specialised in medical devices regulatory compliance and market access.
I cover all main phases of Class I, Class IIa and Class IIb product development and maintenance with an enhanced focus on Medical Device Software (Stand-alone, embedded or as an accessory).
I have extensive knowledge of the regulatory landscape and market access requirements for medical devices in key markets such as: EU, US, Japan and Canada. This includes ensuring compliance with various industry standards, including but not limited to: ISO13485, ISO14971, IEC62304 and IEC82304.
Competences and Services:
- MDSW/SaMD Life Cycle Management & Regulatory Strategy
- Digital Therapeutics (DTx) & Digital Reimbursement
- Medical Device Infrastructure (QMS, ISMS, Audit Management)
- Project Management and Systems Engineering
- Quality Assurance and Design Assurance
- Design Control
- Risk Management
- Requirements Engineering / mngt.
- Usability Engineering
- Design Verification and Validation
- Technical Writer
- Design Input/output deliverables
- Test Protocols and reports
Regulations:
- MDR (EU) 2017/745
- GDPR (EU)
- The German Digital Health Applications (DiGA)
- US, FDAs 21 CFR part 812, part 820 and part 860
- US, HIPAA
Standards:
- ISO 13485
- ISO 14971 (+ISO/TR 24971:2020)
- IEC 62304
- IEC 82304
- IEC 62366-1 and 62366-2
eDMS/eQMS Knowledge:
- GreenLight Guru
- Veeva Vault
- MasterControl
Company Details
- Employees
- 1
- Industry
- Medical Equipment Manufacturing
- NAICS
-
Medical Equipment and Supplies ManufacturingSurgical and Medical Instrument ManufacturingSurgical Appliance and Supplies ManufacturingDental Equipment and Supplies ManufacturingOphthalmic Goods ManufacturingDental Laboratories
- Competitors
- Dawn Health, Dräger, MDRC, Uvisa Health, MedDev Compliance, MTRC, Teton, Arxada.
Mdrc Aps Questions
Mdrc Aps's website is https://www.linkedin.com/in/kristoffer-madsen-34144843/
Mdrc Aps's LinkedIn profile is https://www.linkedin.com/company/mdrc-aps
Mdrc Aps has
1 employees.
View email and phone details for 1
employees at Mdrc Aps.
Mdrc Aps's industry is
Medical Equipment Manufacturing
Mdrc Aps's top competitors are
Dawn Health,
Dräger,
Mdrc,
Uvisa Health,
Meddev Compliance,
Mtrc,
Teton,
Arxada.
Mdrc Aps's categories are Medical Equipment Manufacturing
