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ISO 13485 Consulting
Companies producing Medical Devices should appoint an experienced ISO 13485 Consultant or a consulting...
READ MOREISO 14971 Risk Management
Let’s review the background of ISO 14971. As a medical device manufacturer, the first thing you need to...
READ MORECE Technical File (MDR)
The MDR 2017 / 745 Annex II Medical Device Technical File is a clear, well-organized, easily searchable...
READ MOREInternal & Supplier Audits
We provide audit expertise that can more effectively drive change and improvements. Your internal audit...
READ MOREMDSAP Single Audit Program
MDSAP (Medical Device Single Control Program) is one of the (very) few harmonization programs between...
READ MOREEU MDR - IVDR
Determining the Medical Device Classification and related classification rule is the first step in the EU...
READ MORECE Product Certification
With our CE certification Consultancy service, we help medical device manufacturers commercialize their...
READ MOREFDA Quality System Regulation
With our US FDA 510(k) Consulting service, we help you go through the entire process by thoroughly...
READ MOREDesign, Process & Software Validation
Process Validation is performed to ensure consistent delivery of quality products that meet predetermined...
READ MOREBiocompatibility
A medical device is not expected to evoke any biological response in the patient when used as intended...
READ MOREClinical Evaluation
Clinical evaluation is required for medical devices under medical device directive 93/42/EEC and medical...
READ MOREClinical Data Evaluation
MDR Article 2 (44) defines clinical evaluation as a systematic and planned process to continually...
READ MOREPMS - Post-Market Surveillance
Regardless of the classification of the medical device, Post-Market Inspection is necessary and a...
READ MOREPMCF - Post-Market Clinical Follow-up
Post-Market Clinical Follow-up (PMCF) is part of PMS activities and should be understood as a continuous...
READ MORESSCP - Safety and Clinical Performance Summary
The Safety and Clinical Performance Summary provides healthcare professionals with a summary of clinical data...
READ MOREGAP Analysis in Healthcare
Gone are the days when the family doctor made house calls. Welcome to the modern healthcare industry: a...
READ MOREUTS and EUDAMED Records
Product Tracking System (ÜTS for short), MDR, EUDAMED are among the topics that the medical device...
READ MOREMDR / IVDR Importer & Distributor
As of 26 May 2021, the European Union applies stricter rules on Medical Devices (MDR). From 26 May 2022...
READ MOREIVDR (2017/746) Consulting
We plan your in vitro diagnostic device pathway under EU IVDR 2017/746, from intended purpose and risk classification to performance evidence and submission preparation.
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