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New Product Development Process - Overview

New Product Development Process - Overview. A.Martinmäki. New Product Development Process (PACE). Regulatory requirements. Common sense FDA 21 CFR Part 820 QSR QSR, cGMP IVD Directive 98/79/EC CE mark Notified Body Canadian regulations CMDCAS , ISO 13485 ISO 9001:200 0

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New Product Development Process - Overview

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  1. New Product Development Process- Overview A.Martinmäki

  2. New Product Development Process (PACE) Page 2

  3. Regulatory requirements • Common sense • FDA 21 CFR Part 820 QSR • QSR, cGMP • IVD Directive 98/79/EC • CE mark • Notified Body • Canadian regulations • CMDCAS, ISO 13485 • ISO 9001:2000 • Safety and Electromagnetic Compatibility (EMC) • Chemical Safety • Occupational Safety & Health Administration (OSHA) • Environmental Protection Agency (EPA) • Other standards • National laws Page 3

  4. SOP 1390 3590 New Product Development Page 4

  5. Process flow charts: Planning 1/2 Page 5

  6. Design Reviews • Five Design Reviews: DR1, DR2, DR3, DR4 and DR5 – may be combined in to two reviews. • For example, DR4: Page 6

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