Compliance Consultants can consult with you and assist you in creating the necessary controls to meet
ISO-13485. This the harmonized standard for medical device manufacturing combines the concept of six-
sigma level of quality systems (Good Manufacturing Practices, GMP plus Design Controls).
The difference that we offer compared to ISO auditors is we CREATE the engineering documentation or work with you to create it. We know what the auditors expect to see and we work with you to verify your systems have the appropriate control and reflect that control in documentation. Not more; not less.
Compliance Consultants can audit your processes, then develop a gap analysis. We can mentor you to create the necessary documents that control the processes that you must control. We can review your engineering organization and products. Then we can advise you what is required to meet ISO 13485.
Compliance Consultants can ...
A five-sigma level of certainty a measures how unlikely it is that an experimental result is simply down to chance rather than a real effect. For example: tossing a coin and getting a number of heads in a row may just be chance, rather than a sign of a "loaded" coin. The "three sigma" level represents about the same likelihood of tossing more than eight heads in a row. Five sigma, on the other hand, would correspond to tossing more than 20 in a row. Unlikely results can occur if several experiments are being carried out at once - equivalent to several people flipping coins at the same time. With independent confirmation by other experiments, five-sigma findings become accepted discoveries. A six-sigma level of quality in a Quality System (Good Manufacturing Practices + Design Controls) signifies that you control the processes - so well (that when repeated in manufacturing only) one item out of one million items produced - will have a variance out of specification.
Compliance Consultants does what auditors do not and cannot do. We work with you to create and implement a system that suits your medical device process. We do NOT sell you a pile (or files) of paper where you simply substitute your name and save the file as part of your documentation system.
The difference that we offer compared to ISO auditors is we CREATE the engineering documentation or work with you to create it. We know what the auditors expect to see and we work with you to verify your systems have the appropriate control and reflect that control in documentation. Not more; not less.
Compliance Consultants can audit your processes, then develop a gap analysis. We can mentor you to create the necessary documents that control the processes that you must control. We can review your engineering organization and products. Then we can advise you what is required to meet ISO 13485.
Compliance Consultants can ...
1. Identify applicable portions ISO-13485 that apply
2. Create and implement a Quality System.
3. Identify specifications or guidance documents that you must conform to implement the ISO-13485 Quality System.
4. Develop a Risk Analysis of products to applicable specifications referenced by ISO-13485.
5. Develop validation for a production controls that cover issues raised in the risk analysis.
6. Developing a record system as per applicable specifications referenced by ISO-13485.
7. Identifying and retaining an auditor that you will hire to audit your company and your product to ISO-13485.
2. Create and implement a Quality System.
3. Identify specifications or guidance documents that you must conform to implement the ISO-13485 Quality System.
4. Develop a Risk Analysis of products to applicable specifications referenced by ISO-13485.
5. Develop validation for a production controls that cover issues raised in the risk analysis.
6. Developing a record system as per applicable specifications referenced by ISO-13485.
7. Identifying and retaining an auditor that you will hire to audit your company and your product to ISO-13485.
A five-sigma level of certainty a measures how unlikely it is that an experimental result is simply down to chance rather than a real effect. For example: tossing a coin and getting a number of heads in a row may just be chance, rather than a sign of a "loaded" coin. The "three sigma" level represents about the same likelihood of tossing more than eight heads in a row. Five sigma, on the other hand, would correspond to tossing more than 20 in a row. Unlikely results can occur if several experiments are being carried out at once - equivalent to several people flipping coins at the same time. With independent confirmation by other experiments, five-sigma findings become accepted discoveries. A six-sigma level of quality in a Quality System (Good Manufacturing Practices + Design Controls) signifies that you control the processes - so well (that when repeated in manufacturing only) one item out of one million items produced - will have a variance out of specification.
Compliance Consultants does what auditors do not and cannot do. We work with you to create and implement a system that suits your medical device process. We do NOT sell you a pile (or files) of paper where you simply substitute your name and save the file as part of your documentation system.
