BUSINESS SENSITIVE 1 Copyright © 2009 by James E. Dvorsky, Battelle Medical Device Solutions...

BUSINESS SENSITIVE 1Copyright © 2009 by James E. Dvorsky, Battelle Medical Device Solutions

Compliance Engineering

Jim DvorskyBattelle Medical Device Solutions

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Copyright © 2009 by James E. Dvorsky, Battelle Medical Device Solutions

Introduction to Compliance Engineering

• What is Compliance Engineering? What does it mean to have a compliant product?

• Why is Compliance Engineering important?

• When and where does it begin? When and where does it end?

• How is product compliance achieved?

• Who is responsible for product compliance?

• What role can I play in Compliance Engineering?

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What is Compliance Engineering?

• Compliance Engineering is designing and developing a product to meet a set of safety standards specific to that class of products.

• A compliant product is one that has undergone an evaluation and meets the stipulations set forth by the market.

• The evaluation may be performed by product manufacturer…– CE Marking, Witnessed testing

• …Or may be performed by an independent party.– NRTL, Certifying Body

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Product Safety Requirements

• Where do product safety requirements come from?

• Who oversees the requirements and the products intended to conform to them?

• Can anyone perform a product evaluation?

• Who or what constitutes an independent evaluator?

• Can’t a product just get a safety mark and be done with this process?

• Is electromagnetic compatibility (EMC) different from product safety or just a part of it?

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Alphabet Soup

AAMI ANSI BSI CBCCC CE CEI CISPR CSA

EMC EMI ESD ETLEU FCC FDA GHTF GS

IEC ISO ITS IVDJSA LVD MDD NARTENEMKO NOM NRTL OSHAROHS SEMKO TUV UL VDE

WEEE

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Standards Writing Organizations




WEEE

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Standards Incorporating Organizations




WEEE

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Standards Acceptance and Renaming

• An independent (often international) organization generates a standard based on the consensus of the members participating on the committee– IEC 61010-1

• Members of the European Economic Community accept the standard– EN 61010-1

• Individual countries in EEC accept the standard, with deviations specific to their country– BS EN 61010-1

– DS EN 61010-1

– TSE 61010-1

– GOST-R 61010-1

• Other countries adopt standard, with deviations– UL 61010-1

– CSA-C22.2 No. 61010-1

– JIS C 1010-1

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Standards Testing Organizations




WEEE

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Product Safety Marks




WEEE



But wait, there’s more…




WEEE



Why is Compliance Engineering Important?

• This question requires a two-part answer:

1. Product safety compliance, which may or may not include electromagnetic compatibility, is necessary for acceptance of the product into specific markets.

2. Designing the product with compliance in mind throughout the development process is a proven method of obtaining the desired outcome with maximum efficiency.



When and Where does the Product Compliance Process Begin (and End)?

• It begins with the targeted end user– Determine where you plan to sell your product: specific countries or

regions

– Determine if you would like a product safety mark on the product and which one(s)

– Decisions are Market-driven

• Compliance engineering takes place throughout product development

• Compliance process continues through manufacturing and product placement– On-site inspections

– Customer feedback

• It ends at the end of life for product (device retirement)



Facets of Product Compliance

• Protection of Operator– Electrical shock (hazardous voltages, currents)

– Mechanical hazards (moving parts, pinch, impact)

– Thermal hazards (hot surfaces, fire)

– Radiation (ionizing, optical, acoustic, EM)

• Protection of Patient– Similar to protection of operator, but more stringent

• Protection of Environment– Electromagnetic interference (EMI)



Facets of Product Compliance (con’t)

• Product Installation– Facility requirements

– Instructions

• Operation of Product– User interface (ease of use, interpretation of displays, effectiveness of

interface)

– Alarm features (intensity, frequency content)

– Instruction manual

• Product Maintenance– Operator-performed

– Maintenance personnel

– Training requirements

• Special precautions and circumstances– Unique to product



Hierarchy of Product Standards

• General Safety Standard

– Suited to family of products having similar operating environments or uses

– Standard number has no dash number or “-1”

• Collateral Standard

– Focuses on safety subject that is common to the family, but deserves more detailed attention

– Standard number ends in -1-X, where X is specific to the subject

• Particular Standard

– Focuses on a particular type of product within the family because special or unique attention is required

– Standard number ends in -2-Y, where Y is specific to the sub-classification of products



How is Product Compliance Achieved?

• Product Design

– Always the primary approach to safety

– Prescriptive requirements specified in the standards

– Use of listed products within the scope of their intended use

– Design must always be mindful of maintaining safety under normal (NC) and single-fault conditions (SFC)

• Product Labeling

– Markings on product itself

– Instructions on accompanying documents

• Risk assessment of product

– Documentation supporting risk assessment and decision process

• Following guidelines provided by regulatory body

– FDA



Who is Responsible for Product Compliance?

• Short answer: everyone associated with the product!

• Long answer– Manufacturer is responsible for designing a compliant product

– Independent evaluator stands behind the quality of the evaluation and results

– Manufacturer maintains consistency in manufacturing

– Owner of product safety mark stands behind the quality of the evaluation and results AND performs regular inspections

– User (ultimate customer) operates device as intended and follows instructions

– Manufacturer responds to feedback to modify product or remove it from the market



What role can I play in Compliance Engineering?

• Know and utilize your Compliance Engineering experts

• Be product safety conscious

• Realize that Compliance Engineering is part of the product development process

• Know what you talking about; get educated

• Educate others



“A man’s got to know his limitations.”Harry Callahan

“Magnum Force” (1973)

BUSINESS SENSITIVE 1 Copyright © 2009 by James E. Dvorsky, Battelle Medical Device Solutions...

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