harmonization for safety & effectiveness heavily regulated ... · hematology urinalysis lab...

March, 2008Copyright © Siemens AG 2008. All rights reserved.

Siemens Healthcare, Quality Management

Who can support usIn proving healthcare at its best?

Harmonization for safety & effectivenessHeavily regulated industry: Medical

Copyright © Siemens AG 2008. All rights reserved.March 2008 - International Accreditation Forum, Bonn

Page 2 March, 2008Copyright © Siemens AG 2008. All rights reserved.


Market development in healthcare

Market trends … Demands for …

More efficient and more effectivehealthcare services

Optimized workflow

Rural healthcare products

Supporting healthcare professionals in doing their workefficiently

Growing population

Aging population

Emerging rural healthcare

Cost pressure



The vision of Siemens Healthcare

high quality and patient-centered carealong the healthcare continuumwith best processesand with proven outcomes.

We help our partners to provide …

Workflow-oriented IT

Prevention & early

detection In-vitroDiagnostics(IVD)

In-vivoDiagnostics(Imaging)

DiagnosisTherapy Care



In-vivo diagnostics (major medical imaging systems)

X-Ray ComputedTomography

MagneticResonance

MolecularImaging Ultrasound

Healthcare ITIn-vitro diagnostics (major medical laboratory systems)

Immuno-diagnostics

Nucleid AcidTesting

Clinical Chemistry Hematology Urinalysis Lab

AutomationNear PatientTesting

First fully integrated diagnostics company



Contractual and liability claims

Siemens HealthcareMarket / regulatory complexity

Authorities

Customers

Patients

UsersSiemensHealthcare

Standards

ISO13485: 2003

ISO 14971:2000

IEC 60601-1-x

…

Regulatory Affairs

Europe MDD 93/42/EECIVD-Dir. 98/79/EEC

USA 21 CFR 82021 CFR 809

Canada CMDCAS

Japan PAL

China Order No. 276, …

World GHTF

…



Medical Devices General

Market access is a critical process for medical device manufacturers and for the patients, because it influences the time to market (clinical availability) as well as the commercial aspect (price).

The medical device is identified by the specific legal definition in the respective national legislation. As the definitions differ slightly the assessment (medical device or not?) must consider the differences (e.g. USA vs.EU).

The manufacturer defines the intended use of the medical device which is compared with the respective legal definition. The intended use typically covers:



Medical Devices Manufacturer

The manufacturer is the responsible legal entity placing the medical device on the market. This means that other companies can supply or produce components or complete systems, but are not manufacturers in the regulatory sense.

When multiple companies work jointly on a research project, the responsibilities must be clearly outlined. Either one single partner or a joint venture can assume the full responsibility for that device.

Aspects of product liability and intellectual property need also be considered.



Medical Devices Manufacturer

The manufacturer defines the intended use and the device with its accessories , interfaces etc. The risks are controlled through product risk management (acc. ISO 14971) and identify potential risks from the workflow, clinical application or third party products/markers.

When placing the devices on the market the manufacturer must ensure compliance with regulatory requirements (e.g. QMS, safety standards).

This traditional device oriented regulatory approach has some challenges when solutions (containing a combination of multiple devices) are developed. In this case the solution must “fit into the frame”. In general this means that the responsibilities for the manufacturer/s of system/solution must be clearly defined.

1. Define User group(Employees of AtlantiCare)

2. Updating Data in MA DB via web-interface

3. MA Card productionand distribution

ED Szenario/Kiosk

RFID Reader

MACard

Internet

SBS RFID Middleware

A) Read unique member ID

B) Request of PHR Data

C) Print PHR Data

MedicAlert DB

SBS RFID-Middleware

Web-Service

Printer

Web-Service



Medical DevicesClosing the Loop

PRE-MARKET POST-MARKET

PLACING ON THE MARKET



Conformity Assessment Procedure

Device Classification

Medical Device(intended use defined)

Affixing of CE Mark

Declaration of Conformity

Placing on the market

Product Type Listing

Establishment Registration

Essential Requirements

Intended Use of Medical Device

9999** Number assigned to NB

by EU Commission

Medical Devices Path to Market in the European Union



Medical Devices Path to Market in the United States

Product Classification(defined by FDA)

Medical Device(Intended use)

Product Type Listing

Market Access

Establishment Registration

Market clearance/approval by FDA*

•Premarket Notification [510(k)], or

• Exempt from 510(k), or

•Premarket Approval

Quality System Regulation



Medical DevicesSafety & Effectiveness

Once state of the art…



State of the art technology develops continuously through systematic evaluation of post market data.



Medical DevicesPost Market Surveillance

To prevent adverse events (e.g. injury) it is necessary to have quick access to comprehensive and reliable post market information.

The international exchange of post-market information between authorities is increasing in the last years.

This “alert-network” is needed to protect the patients and users globally.



USA(QSR)

Canada

PRC

...

South America

Australia

Japan

EU

1348513485

ISO 13485:2003One common standard



USA(QSR)

Canada

PRC

...

South America

Australia

Japan

EU

1348513485

JGMP Report

Certification

Certification & inspection

ISO 13485:2003One common standard & multiple audits

FDA Inspections

CMDCS Certification

EC certificate

Registration & inspectoins



ConcordOCS

Hoffmann Estates(Chicago)

MIAX Piscataway

A

KnoxvilleMI

Oxford MR Erlangen/Forchheim

AX, SP, CT, MR, AHS, CO, RV, SW, CS

Madrid SP

SingaporeA

Shanghai CT, AX, CO

Malvern HS

Mountain ViewUS

Suzhou A

Shenzhen MR

Goa CO

Kemnath CO

Rudolstadt RV

Kyongju-siUS

Indonesia A

WuxiRV

BangaloreHS, IKM

Divisions/HeadquartersManufacturing sites

~49,000 employees worldwide (after closing of Dade Behring acquisition)

Dublin DX

FlandersDX

IssaquahUS

Siemens HealthcareGlobal presence & multiple organizations

LlanberisDX

SudburyDX

Heidelberg OCS

SeoulUS

Cary CS

ElkhartDX

Walpole DX

Marburg DX

New Jersey DX

Wales DX

DeerfieldDX

TarrytownDX

Los AngelesDX



Integration versus Cummulation

Integrate4Efficiency Management SystemsAudit Requirements

Quality ManagementISO 13485:2003ISO 9001:2000EC CertificateCanada, Japan, Taiwan, etc

Environmental Management ISO 14001

Financial ControlsSOA

Information TechnologyISO 27001

Process ImprovementCCMi

…



Added Value

Audits

Inspections

Assessments

Certificates

1.

4.3.

2.Market Access Outsourcing

Tenders Compliance

Accepted controlsCustomer Requirements

Regulatory Requirement Indicator for Quality

Enable the manufacturer to control the operations for placing safe and effective medical devices on the market and ensure a high customer satisfaction



Harmonization for safety & effectivenessConclusions

Complexity in a highly regulated environment

Support integration and reduce complexity

Standardization in auditing must provide tangible benefits

1.

2.

3.

Transparency is needed for market control and trust building4.



Thank you!

Dr. Gerd [email protected]

Carlos [email protected]

Siemens AGHealtcare SectorHenkestr. 127D - 91052 Erlangen

Siemens HealthcareAnswers for life

March 2008

International Accreditation Forum, Bonn



Biography

Carlos Arglebe is the head of the Quality Management System and Processes Unit at Siemens Healthcare, based in Erlangen (Germany).

His responsibilities include the global development of process- and quality management. Amongst others, his focus is set on Product RiskManagement, the Corporate Quality & Regulatory Competency- and Compliance Audits Program.

He has a degree in law, an MBA in Health Care Management and large experience in Quality Management Systems.

Since 2007 he represents the medical device industry of the European Union as member of the Global Harmonization Task Force (StudyGroup 3 - Quality Systems).



SynopsisHarmonization for safety & effectiveness

The industry sector of medical devices is heavily regulated on a global

scale. There are multiple regulatory models which have distinct

requirements but a common objective: ensure safety and effectiveness.

The ISO 13485:2003 quality management standard is well accepted

and broadly implemented, providing a common basis for global

operations. The standard is process oriented, supporting the fact that

product quality is determined by a company’s processes. Quality

Management Systems have therefore become a key requirement for

market access. Although a common standard exists, the number of

audits and inspections increased in the last years due to country

specific requirements and the lack of mutual recognition of existing

certificates. This is in many cases the cause for redundancies which

impact the operations of the manufacturer. Minimizing auditing efforts

without imparing the effectiveness of Quality Management Systems

must be a common objective.

Covering multiple applicable standards and regulations into one audit is

a valid solution and an efficient approach. This reduces redundancies

and the burden set on the manufacturer (time & effort).

In this context the calculation of audit man-days needs to be further

developed, so that such a combined audit does not cummulate, but

integrate the applicable requirements. There is no direct correlation of

man-days and the number of employees. Instead it is the process

complexity, the amount of automation and the level of risk which are of

relevance. Additionally the knowledge gained by the certification body

throughout the years allows a more focussed and in deapth auditing

compared to an initial audit by a third party.

To improveme competiveness and the reliability of certifications, more

transparency about the certification bodies with a warning system

similar to medical device manufacturers is a new approach which

should be evaluated.

harmonization for safety & effectiveness heavily regulated ... · hematology urinalysis lab...

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