MEDTECH CONSULTING PHASES

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1- MTG Pre-Assessment (*Free)

Intensive initial Data collection. 

MTG  Free Pre- Assessment report.

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2- MTG Gap Analysis:



-Current State vs  Requirements. 


- Process Optimisation elements. 



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3- MTG Implementation


-Plan

-Do

-Check

-Act


Production. Quality. Compliance. Product Safety. 

Medical Devices : European Union

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CE Marking

CE marking  is mandatory, allowing your technology to be placed  on the market in any European  Union member state.   There are procedural steps for CE marking, such as fulfillment of technical conditions and requirements for safety and functionality. 

Quality and Risk Management Systems

ISO 13485 for Quality Management Systems and ISO 14971  for Risk Management  are harmonised standards  totally aligned with European regulatory and product safety requirements.  A robust implementation  throughout  your product lifecycle is the recommended strategy to follow in order to achieve compliance.

Post Market Surveillance System

Post Market Surveillance is required   throughout  your product lifecycle with outputs to Risk Management. 

Conformity Review

Technical Conformity reviews of products, systems and documents.  Regulatory expertise assessment for compliance with EU current regulatory requirements ,MDR and IVDR requirements. 

IFU, Labelling and Packaging

Instructions for Use (IFU), Labelling and Packaging requirements  are key elements  in product regulatory compliance and they are subject to specific country regulations. 

Audits


It is mandatory to conduct  audits at planned intervals. Auditing is a systematic, independent and documented process  for obtaining evidence to determine the extent to which the Medical Devices Quality Systems and Regulatory requirements are fulfilled. 

Medical Devices: U.S.A.

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Premarket Approval applications

 A PMA application involves many volumes of material to be submitted to FDA. The volumes include device description and intended use, nonclinical and clinical studies, case report forms, manufacturing methods, labeling, etc. Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of medical devices.   PMA requirements apply to Class III devices, the most stringent regulatory category for medical devices.  

Premarket 510(k) Notifications

A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device  that is not subject to PMA. Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalence claims. 

510(k) and Design Controls 21 CFR Part 820.30

 All manufacturers (including specification developers) of Class II and III devices and select Class I devices are required to follow design controls (21 CFR 820.30) during the development of their device. The holder of a 510(k) must have design control documentation available for FDA review during a site inspection. In addition, any changes to the device specifications or manufacturing processes must be made in accordance with the Quality System regulation (21 CFR 820) and may be subject to a new 510(k). 

21 CFR Part 820 Quality System Regulations

 Each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical device(s) designed or manufactured, and that meets the requirements of this part. 

21 CFR Part 11 Electronic Records and Signatures

 Part 11 applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in Agency regulations. 

Medical Device Labeling

FDA develops and administers regulations under authority granted by laws passed by Congress tLabeling regulations pertaining to medical devices are found in the following Parts of Title 21 of the Code o f Federal Regulations (CFR).

General Device Labeling - 21 CFR Part 80

Use of Symbols - 21 CFR Part 801.15

In Vitro Diagnostic Products - 21 CFR Part 809

Investigational Device Exemptions - 21 CFR Part 812

Unique Device Identification - 21CFR Part 830

Good Manufacturing Practices - 21 CFR Part 820

General Electronic Products - 21 CFR Part 1010