Your Prestigious Partner to reach your business objectives€¦ · SOP’s. Compliance with regulatory,Client and local legislation requirement Commo LA’s tailored site weightings

Your Prestigious Partner

to reach your business objectives

Medical Devices

Project Management, QA/RA, Lean

& Support Services

This document or any portion thereof shall not be reproduced or used in any manner whatsoever without the express written permission of Gemar. Copyright © 2015 - 2020 Gemar presentation are property of Gemar srl or an affiliate. All rights reserved

Around the globe, Gemar assists companies bothlarge and small to successfully bring their medicaldevice and IVD products to the market byproviding expert regulatory services andstrategies throughout the product life-cycle.

We help our clients maximize the value of theirproducts by developing innovative and cost-effective solutions, tailored to meet the needs andobjectives of each and every client.

GEMAR 04/01/2016 2

Mission

REGULATORY AFFAIRS & MORE

Navigating the new health

In Italy, specifically in Medolla , near to Mirandola which is a small town with a population of about 22,000, located in the extensive plain of Emilia-Romagna, a region in the North of Italy, 200 Km away from Milano, 50 from Bologna and 60 from Verona.

Until the sixties Mirandola area had been mostly devoted to agriculture.

Afterwards, on the initiative of a local chemist-entrepreneur, a consistent industrial development occurred and the main multinational companies of the medical field invested here.

Several leading companies like Fresenius, B.Braun, Baxter, Bellco, Sorin and Medtronic are present with production plants. Also Sandoz, Pfizer have been active here in the past few years.

GEMAR 04/01/2016 3

Roma

Bologna

VeneziaMilano

Mirandola

MILANO

MIRANDOLA

Where are we based ?


GEMAR 04/01/2016 4

Key Milestones


2004

• Gemar foundation

• Consultancies on Quality Assurance and Regulatory Affairs for medical devices

2010

• Based on market request

• Support on Design Control, Process & Computer System validation

2011

• Based on market request

• Support on Maintenance System Management

2014

• Following market requests

• Support on Lean

2015


• Support on Energy consumption analysis and Financial Saving

2015


• Import – Export for medical devices

Customer Requirements

Accreditation

Import-Export medical devices

Process andSWvalidation

Maintenance System Management

QualityManagementSystem

ProjectsManagement

Regulatory Affairs worldwide for medical devices

Lean

Energy Management

Main Consulting Services


Project Management

Gemar can assist you at every step

GEMAR 04/01/2016


Assess Analyse Design Implement Go live Maintain

Business

Implementation

Training

Support

Business Technical Consulting

Project Managent

6

GEMAR 04/01/2016

Project Management

control milestones

Prior art search and non infringement studies Invention disclosure Voice of the Customer methodology (VOC) Users Requirements Analysis to define Uses Specifications Device System and Sub-system analysis Risks Management Prototyping and Bench Testing Design Reviews Verification & Validation, Design Transfer Project Management fulfilling Medical Devices Regulations: Design Control and DHF filing Definition of Regulatory Affairs data from Design

Navigating the new health7

Design

GEMAR 04/01/2016

Regulatory Affairs International & MORE

Gemar can assist you at every step of

HHS/FDA/CDRH

‐ Regulatory Strategies in EUand RoW

‐ Global Regulatory Consultingfor Medical Device and IVD

‐ Regulatory Gap Analysis‐ Creation of a Regulatory

Dossiers‐ Global Medical Device

Registration and Approval‐ EC Representative service (AR) ‐ US agent service

Navigating the new health8

… next

RA activities

GEMAR 04/01/2016


Gemar can assist you at every step

‐ Risk Management File‐ Response to agency queries‐ Agency meetings‐ Advisory Committee

preparation‐ Scientific Advice and Protocol

Assistance‐ Lifecycle management‐ Input from Subject Matter

Experts


HHS/FDA/CDRH

9

RA activities

GEMAR 04/01/2016

Clinical Studies Worldwide & MORE

Gemar can assist you during

‐ Clinical Investigation Study‐ Design and Protocol

Development‐ Clinical Investigation

Management for Medical Devices

‐ Clinical Evaluation Reports and Literature Review for Registered Medical Devices

‐ Clinical Consulting


HHS/FDA/CDRH

10

Clinical Studies

GEMAR 04/01/2016


We’ve got You

Thanks to our worldwide network , we can initiate your medical devices registration and approval in key markets such, as USA, Canada and Australia as well as Brazil, Russia, India or China.


Associate Partner (New York, USA)

Partner Associate(Jointville , SC, Brasil)

Partner Associate(Seoul, South Korea)

Partner Associate(Guangzhou, China)

Headquarter(Modella, Mo, Italy)

Partner Associate(Munich, Germany)

Partner Associate(Angelholm, Sweden)

Associate Partner (New York, USA)

Partner Associate(Jointville , SC, Brasil)

Partner Associate(Seoul, South Korea)

Partner Associate(Guangzhou, China)

Headquarter(Medolla, Mo, Italy)

Partner Associate(Munich, Germany)

Partner Associate(Angelholm, Sweden)

Partner Associate(Amsterdam, Netherland)

11

covered

GEMAR 04/01/2016

Quality Management System

Gemar can assist you to define your


Our experts are there to assist you in setting up your Quality and Risks ManagementSystems, in compliance with national and international requirements by offering:

Development of Quality Management System

ISO 13485 and US FDA QSR Consulting and Certification for Medical Device Manufacturers

Implementation of Pre-production Quality Management System

Quality System and GMP audit

CMDCAS for Canada medical device registration,

Brazilian GMP, Japan PAL, CFDA regulations.

MINIMIZE RISK MAXIMIZE QUALITY

12

Quality and Risk Management

GEMAR 04/01/2016

Process Validation & MORE

Gemar can assist you to define , including:


Effective process development (ensuring we fully understand ourprocesses)

Design Space (establishing/verifying)

Identifying Critical Quality Attributes and establishing Critical ProcessParameters and their inter-relationships

Quality by Design (QbD) (21 CFR, ISO 13485, ICH Q8 and Q11)

Use of Risk Assessment tools

Latest regulatory guidance (USFDA, EMA & 2015 EU Volume 4 [GMP] Annex 15

13

… next

Process Validation

GEMAR 04/01/2016

Process Validation & MORE



Process Validation approaches for:

Small and large molecule Active Pharmaceutical Ingredient(API) manufacture

Pharmaceutical products manufacture (fill/finish type activities)

Pharmaceutical Packaging

Medical Devices and IVD Devices manufacture

Maintaining the Validated State

Continued Process Verification

Statistical process control

Quality Systems, e.g. effective change control

14

Process Validation

GEMAR 04/01/2016

Computer System Validation



System specifications

Functional specifications

Security

Back-ups

Validation:

Hardware

Software

15

CS Validation

Your is just asimportant as every other aspect of your production process, and is crucial to the quality of your products.

Gemar consultants can assist you with the optimizationand management of your maintenance procedures.

From data management to performance measurement, we will analyze your current system and provide youwith the tools and procedures necessary to ensure thatnothing gets in the way of your production goals.


Total Maintenance System Process

… next

Assistance with data migration betweenmaintenance administration systems

Performance measurement of maintenance plans

Programming optimizations that produce costsavings

Optimization of maintenance processes from an Reliability Centered Maintenance (RCM) perspective

Revision and/or issuing of SOP for maintenanceadministration


Gemar can assist you to define the main steps in maintenance planning, including:

… next

GEMAR 04/01/2016


Gemar can assist you to define Your


Client Needs ServicePartner

StrongFinancial impact

Solutionsfor ourpeople

Adherenceto quality

Sustain or improveSLA’s

Flexible andhighlyresponsive service

GemarSolutions

Site & account staffing and contracting approach, reduced transactional complexity

Site specific financial savings commitment

People on the ground who live there and understand the Client local culture

Site specific Quality Protocols and SOP’s.Compliance with regulatory, Client and local legislation requirement

Common SLA’s tailored site weightings and standards

A proven governance structure that allows flexibility. A scalable and flexible pricing structure

GemarEvidence

Our score has increased year on year globally

Savings generated will deliver over the initial 5 year period of the contract

We have peopleacross thecountries in scope,

Services deliveredby quqlifiedsuppliers ensures compliance

Gemar achievedsimilar savingswithout downward adjustment of SLA’s

An established footprint and high levels of maturity per country allows the service to suit demand

Outcomesfor Clients

18

Total Maintenance System Process

GEMAR 04/01/2016

Lean & MORE


Why do embrace ?

1. Reduce lead time, turning as quickly as possible customerorders into profit

2. Increase profit by reducing costs and increasing sales

3. Best use of resources , developing simultaneously skills

19

… next

Lean

GEMAR 04/01/2016

Lean & MORE

Gemar can assist you to define


1. Approach to improvement, based on the integration of problem solving methods

2. Research and focus on key factors for processes in supportof business strategy

3. Optimization , standardization and control of key factors

20

… next

Lean Roadmap

GEMAR 04/01/2016

Lean & MORE

Gemar can assist you to implement in the followingmilestones:


1. Performance Assessment : evaluation of current processes and wastes (As Is)

2. Opportunity Definition : identification of opportunities (To Be)

3. Improvement Initiatives : support for the implementation ofimprovement projects

4. Control of Results : measure of improvement projects efficiency

21

Lean

GEMAR 04/01/2016

Lean & MORE


concepts and Tools include:

Takt Time

Standardized Work

One Piece Flow or Continuous Flow

Pull Systems and Kanban

Five Why's

Quick Changeover / Single Mimunite Exchnage of Dies (SMED)

Mistake Proofing / Poka

Heijunka / Leveling the Workload

Total Productive Maintenance (TPM)

Five S

A-3 Problem Solving / PDCA / PDSA

22

Lean

GEMAR 04/01/2016

Energy Management & MORE

Gemar can assist you to define ,

including Energy Consumption Analysis and Financial Saving:


Establishing a Management System,

Energy Audit

Energy Saving for Energy-Consuming Systems, e.g.:

Power Distribution Systems

Lighting Systems

Compressed Air Systems

Air-Conditioning and Ventilation Systems,

Injection-Molding, mixing, filling and packaging Systems

23

Energy Management Process

GEMAR 04/01/2016

Import-Export mds & MORE

Gemar can assist you to define Your


Support to identify suppliers and distributors in the EMEA countries

Definition of importation procedures from Extra EU countries

Definition of Incoming inspections procedures

Logistic Management System

Management of national public tenders, including review of tender requirements, offers and tenders documents writing,

Updating of legal requirements for national tenders

24

Import-Export service for medical devices

GEMAR 04/01/2016

Questions & answers


?

25

GEMAR 04/01/2016

Contact us & MORE

How can we help you?

Call or contact us today, we’ll be more than glad to answerany questions you might have and find the solution that fitsyour needs!

Gemar s.r.l.Regulatory Affairs & More

REGISTERED OFFICE & HEADQUARTERVia G. Puccini, 1 I- 41036 Medolla (Mo) - ItalyTel. / Fax. +39 (0) 535 52161http://www.gemarmed.com

Gemar s.r.l.Regulatory Affairs & More

BRANCH OFFICEVia G. Amendola, 43 I- 41036 Medolla (Mo) – ItalyTel. + 39 (0) 535 731216Fax. + 39 (0)535 [email protected]

26This document or any portion thereof shall not be reproduced or used in any manner whatsoever without the express written permission of Gemar. Copyright © 2015 - 2020 Gemar presentation are property of Gemar srl or an affiliate. All rights reserved

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Your Prestigious Partner to reach your business objectives€¦ · SOP’s. Compliance with regulatory,Client and local legislation requirement Commo LA’s tailored site weightings