30+ Years in the Medical Device Industry Medical Device Regulatory Affairs + EU MDR
Consulting Services
Quality Assurance & Regulatory Affairs
Meet medical device regulatory requirements with implementation of a quality management system that meets the requirements for:
ISO 14385:2016 Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes
ISO 13485:2016 MDSAP for Australia, Brazil, Canada, Japan and the US
US FDA 21 CFR Part 820 Quality System Regulations
Canadian Medical Device Regulations - SOR/98-282
European Medical Device Regulations - Regulation (EU) 2017/745
US Federal Food and Drug & Cosmetic Act (FD&C Act) - 21 CFR Parts 800 TO 1299
Medical Writer - EU MDR & MEDDEV Compliance
Literature search plans & reports [LSP/LSR]
Clinical evaluation plans & reports [CEP/CER]
Upgrades to meet requirements for EU MDR
Conformance with MEDDEV 2.7/1 Rev 4
Class 1S, Class 1M, Class IIa, Class IIb, & Class III medical devices
Medical Device Submissions - Canada & Europe
Writing technical files, submitting, & obtaining licensing/CE Marking for:
Class I Establishment License in Canada
Class II, Class III, & Class IV medical devices in Canada
Class I CE Marking in Europe
Class IIa, Class IIb, & Class III CE Marking in Europe
Medical Device Submissions - USA
Q-Sub Meetings
513g submissions
Electronic filing of 510(k) and clearance of the device
De Novo filings and clearance of the device
PMA filings and approval of the device
Risk Management
Conforms to ISO 14971:2019
Conforms to ISO/TR 24971:2020
Risk management plans [RMP]
Hazard identification, risk estimation, and risk assessment
Risk management reports [RMR]
Ailsa Biomedical Regulatory Consulting
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