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Design and development of medical device

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Malesh M
Malesh M
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DESIGN AND DEVELOPMENT OF MEDICAL DEVICE Steps for Design & Development The need of Design and Development in Medical device Industry and the main steps involved in the process Malesh M www.i3cglobal.com 8/10/2013
DESIGN & DEVELOPMENT MEDICAL DEVICE The requirements of Design and development for Medical Device is mentioned in ISO 13485 ,the organization should establish Documented procedure for the design and development and should cover design and development stages including review, verification ,validation and transfer. DESIGN AND DEVELOPMENT PLANNING Based on the information gathered in Product design request, design & development planning is carried out by identifying design & development stages & the target date. Design and development plan includes review, verification & validation that are appropriate to the design & development stages. http://www.i3cglobal.com +91 9900 3218 14
DESIGN & DEVELOPMENT INPUTS Inputs related to the product (system specification & product specification) are determined & recorded in Product design request. Functional performance requirements, applicable statutory / regulatory requirements ,competitors specification are considered for design & development inputs. DESIGN AND DEVELOPMENT OUTPUTS Following are the design & development outputs: i Drawings. ii. Bill of material. iii. Quality plan. iv. Quality inspection reports. http://www.i3cglobal.com +91 9900 3218 14
v. Instruction production & QA. Design calculations for the system / product are recorded in the design work sheet Work sheet Design & development outputs are reviewed so that they meet input requirements. DESIGN AND DEVELOPMENT REVIEW At suitable stages as indicated in the design & development planning, systematic reviews are conducted to evaluate the ability of design to meet the input requirements & identify any problems for necessary actions by the technical team. These reviews are recorded in the design & development record http://www.i3cglobal.com +91 9900 3218 14
DESIGN AND DEVELOPMENT VERIFICATION Verification of design is carried out by QA inspecting & testing for the subsistence of design to ensure that the design and development outputs have met the design and development input requirements. DESIGN AND DEVELOPMENT VALIDATION Validation is performed to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use. Records of the results of validation are maintained in the validation report. CONTROL OF DESIGN AND DEVELOPMENT CHANGES Design & development change requested by any department is recorded in the design change review format and is forwarded review & approval. http://www.i3cglobal.com +91 9900 3218 14
DESIGN & DEVELOPMENT MEDICAL DEVICE DESIGN AND DEVELOPMENT PLANNING DESIGN AND DEVELOPMENT VALIDATION CONTROL OF DESIGN AND DEVELOPMENT CHANGES http://www.i3cglobal.com DESIGN & DEVELOPMENT INPUTS DESIGN AND DEVELOPMENT VERIFICATION DESIGN AND DEVELOPMENT OUTPUTS DESIGN AND DEVELOPMENT REVIEW DESIGN TRANSFER +91 9900 3218 14

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Design and development of medical device

  • 1. DESIGN AND DEVELOPMENT OF MEDICAL DEVICE Steps for Design & Development The need of Design and Development in Medical device Industry and the main steps involved in the process Malesh M www.i3cglobal.com 8/10/2013
  • 2. DESIGN & DEVELOPMENT MEDICAL DEVICE The requirements of Design and development for Medical Device is mentioned in ISO 13485 ,the organization should establish Documented procedure for the design and development and should cover design and development stages including review, verification ,validation and transfer. DESIGN AND DEVELOPMENT PLANNING Based on the information gathered in Product design request, design & development planning is carried out by identifying design & development stages & the target date. Design and development plan includes review, verification & validation that are appropriate to the design & development stages. http://www.i3cglobal.com +91 9900 3218 14
  • 3. DESIGN & DEVELOPMENT INPUTS Inputs related to the product (system specification & product specification) are determined & recorded in Product design request. Functional performance requirements, applicable statutory / regulatory requirements ,competitors specification are considered for design & development inputs. DESIGN AND DEVELOPMENT OUTPUTS Following are the design & development outputs: i Drawings. ii. Bill of material. iii. Quality plan. iv. Quality inspection reports. http://www.i3cglobal.com +91 9900 3218 14
  • 4. v. Instruction production & QA. Design calculations for the system / product are recorded in the design work sheet Work sheet Design & development outputs are reviewed so that they meet input requirements. DESIGN AND DEVELOPMENT REVIEW At suitable stages as indicated in the design & development planning, systematic reviews are conducted to evaluate the ability of design to meet the input requirements & identify any problems for necessary actions by the technical team. These reviews are recorded in the design & development record http://www.i3cglobal.com +91 9900 3218 14
  • 5. DESIGN AND DEVELOPMENT VERIFICATION Verification of design is carried out by QA inspecting & testing for the subsistence of design to ensure that the design and development outputs have met the design and development input requirements. DESIGN AND DEVELOPMENT VALIDATION Validation is performed to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use. Records of the results of validation are maintained in the validation report. CONTROL OF DESIGN AND DEVELOPMENT CHANGES Design & development change requested by any department is recorded in the design change review format and is forwarded review & approval. http://www.i3cglobal.com +91 9900 3218 14
  • 6. DESIGN & DEVELOPMENT MEDICAL DEVICE DESIGN AND DEVELOPMENT PLANNING DESIGN AND DEVELOPMENT VALIDATION CONTROL OF DESIGN AND DEVELOPMENT CHANGES http://www.i3cglobal.com DESIGN & DEVELOPMENT INPUTS DESIGN AND DEVELOPMENT VERIFICATION DESIGN AND DEVELOPMENT OUTPUTS DESIGN AND DEVELOPMENT REVIEW DESIGN TRANSFER +91 9900 3218 14