QUALITY MANAGEMENT SYSTEM
SIC can provide practical and efficient SOPs for: ISO…
WHY WORK WITH US
Professional
Know exactly what should be prepared to comply with regulations
EXPERIENCE
Ex EU Notified Body Staff
STRONG TEAM
Regulatory Quality competence
REASONABLE COST
Charge for work performance no hidden cost
4 MAIN REASONS TO CHOOSE US
Our Services
PRE-MARKET SUBMISSION
Creation of US Pre-Market Notification (510k) Creation of Technical…
Training
Design and Development Requirements for Medical Devices Training
COURSE OUTLINE The FDA Quality System Regulation, 21 CFR Part 820, ISO 13485:2016 and Medical…
ISO 14971:2019 Application of Risk Management to Medical Devices Training
COURSE OUTLINE Practical workshops throughout the day are also provided in order to give you…
Medical Device Single Audit Program (MDSAP) Fundamentals and Readiness Training Course
COURSE DESCRIPTION The Medical Device Single Audit Program (MDSAP) allows medical device manufacturers to meet…
Recent Regulatory News
UK MEDICAL DEVICE REGULATOR PROPOSES A 12 MONTH DELAY FOR UKCA REQUIREMENTS AND THE NEW MEDICAL DEVICE REGULATIONS
On Friday 21st October 2022, the Medicines and Healthcare Products Regulatory Agency (MHRA) wrote to…
Extended IVDR transition period for certain IVD medical devices
The European Union is proposing to delay the go-live date for the incoming medical device…
UKCA Marking Delay: One Year Extension to the Acceptance of CE Marking in UK
The UK Government has announced an extension to the acceptance of CE marking in the…