José Mora
José Mora
José Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and quality systems. Prior to working full time as a consulting partner for Atzari Consulting, José served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem solving, and quality system methodologies. During that time he prepared a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment.
José led the launch of manufacturing at a start-up urology products company as Director of Manufacturing for UroSurge, Inc. at the University of Iowas business incubator park in Coralville, IA, creating a world-class medical device manufacturing operation, with JIT, kanban systems, visual workplace and lean manufacturing practices. José worked for 10 years at Cordis Corporation, now a Cardinal Health company, where he led the successful tooling, process development and qualification of Cordis first PTA (percutaneous transluminal angioplasty) catheter.
His medical device experience includes surgical instruments, PTA & PTCA dilatation and guiding catheters, plastic surgery implants and tissue expanders, urology implants and devices for the treatment of incontinence, delivery systems for brachytherapy, orthopaedic implants and instruments, and vascular surgery grafts and textiles. During his time at Cordis, José managed the Maintenance and Facilities Department, taking that operation to a level rated as tops by the UK Department of Health and Social Services (DHSS) during one of their intensive audits. Jose managed Manufacturing Engineering as part of the Guiding Catheter Core Team of managers, a team that took the Cordis Guiding Catheter business to lead the market, bringing it up from fourth place. By introducing world-class techniques, the Guiding Catheter design and manufacturing was completely re-engineered for robust design and tooling, under José’s leadership.
He was also instrumental and played a leadership role in the complete re-engineering of the Tooling Control System, including design drafting, the tool shop and technical support. Wherever he has worked, he has a track record of introducing world-class methodologies such as Kepner-Tregoe, Taguchi techniques, Theory of Constraints, Lean Manufacturing, Five S (Visual Workplace), process validation to Global Harmonization Task Force standards, and similar approaches.
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Deconstructing the EU MDR with Principles of Lean Documents and Lean Configuration
The EU MDR is a comprehensive and complex regulation that combines all aspects of placing certain types of medical devices on the EU market into one regulation. It addresses the obligations of economic operators in this role, and provides... -
Project Management Utilizing Principles of Lean Documents and Lean Configuration
Project Management involves not only the management of tasks and task owners, but also of information involving documents, records, and many other elements. The traditional approach is to compile, create and push these through the various stages. The concept... -
2-Day Virtual Seminar on Supplier and Contract Manufacturer Management
This 2-day course will cover managing a supplier for the entire lifecycle of the relationship, beginning with identification and qualification of a supplier and continuing through building a relationship, risk management, ongoing assessment (including auditing) and finally planning for... -
Effective Design of Experiments (DOE) Strategies
The effective and progressive use of a Screening DOE, a Mapping DOE and a Robust Process DOE will lead to a better understanding of the process and the location of the best optimum. NOTE: This webinar does not focuses... -
FDA Regulations and Requirements for Artificial Intelligence / Machine Learning
AI/ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical software by means of regulation and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidance.... -
How To Conduct A Human Factors/Usability Validation
This webinar will explain the procedure described in ISO62366 and the FDA Guidance for compliant human factors/usability validation. HF/U validation is very different from device validation. For example, success criteria are qualitative rather than quantitative as is in device... -
Design History File (DHF) Remediation using Principles of Lean Documents and Lean Configuration
Does your DHF remediation process resemble the very mess that it is trying to resolve? The Design History File (DHF) is the objective evidence that a medical device was designed per design control guidance and applicable regulations and standards.... -
Supplier Quality Remediation using Principles of Lean Documents and Lean Configuration
Does your Supplier Quality remediation process resemble the very mess that it is trying to resolve? Receiving Inspection (RI) and First Article Inspection (FAI) may appear to be the beginning of the manufacturing process. In fact, they are the... -
Risk Management using Lean – Are you sure your documents are clutter free?
“The new standard expects you to apply a ‘risk based approach’ to your organization’s QMS processes. The old standard also expected you to think about risk, but only during product realization (in section 7). Now, you’re expected to apply... -
3-Hour Virtual Seminar on IEC 62304 and Demystifying Software Validation using the Principles of LDLC
If your company need to file for 510K approval for Software as a Medical Device (SaMD) or software enabled medical Devices to the FDA for, this webinar is for you. After waiting for seven or more months to find... -
Test Method Validation to Verify your Device Performance
Test method validation is an often confusing requirement for medical devices. A fundamental issue is the role-reversal between the test method and the product or process it is designed to detect. For example, while a defect-free process is desirable,... -
Managing The Audit Function In A Global Company
Audits on their own are simple efforts to identify non-conformances and deficiencies in a process or a system. Independent examination and unique problem-solving skills are essential for identifying and solving complex issues. Employees and functions in this auditing role... -
Risk-based Design Control – The New Paradigm for Medical Device Design
Risk management is a process that involves the identification of the many considerations, responsibilities, personnel, and the transfer of knowledge. Medical device risk management helps gauge the possible hazards under both normal and fault conditions. It is understood that... -
Process Validation Requirements and Compliance Strategies
This Process Validation Requirements webinar will review process validation basics, with emphasis on looking beyond compliance towards achieving a robust process. Review of process validation basics, with emphasis on looking beyond compliance towards achieving a robust process. When used... -
Demystifying Design Inputs – Design Outputs, Traceability Matrix
Design controls involve the translation of user requirements (aka Voice of the Customer) into specific technical requirements as design inputs. These design inputs then form the basis of the design specification, which becomes the design output. Since design controls... -
Through the Eyes of an Auditor
Internal and external audits are an integral part of running a medical device or biotechnology manufacturing operation. To be sure, auditors must follow standards such as ISO 13485, ISO 14971, or regulations such as 21 CFR Part 820. Additionally,... -
Risk Management for Medical Devices per ISO 14971 2007
Risk management overarches projects associated with a particular product family, given that risks will both remain and change as new design features and medical indications for use evolve with a particular device. During all phases of a project, any... -
Demystifying Design Inputs – Design Outputs, Traceability Matrix
Design controls involve the translation of user requirements (aka Voice of the Customer) into specific technical requirements as design inputs. These design inputs then form the basis of the design specification, which becomes the design output. Since design controls... -
Sale!
Supplier Quality Management Simplified
Changes in technologies and supply-chain arrangements have coincided with the expansion of regulations and standards to the entire supply chain. Unfortunately, many suppliers have not kept up or find themselves in a strange new world. It would be a... -
Sale!
Creating Design History Files (DHF), the Device Master Records (DMR) and the Device History Records (DHR), Utilizing the Principles of Lean Documents and Lean Configuration
The Theory of Lean Documents is the product of applying lean principles to the creation, design, process, and management of controlled documents typically found in regulated industries. Just as lean principles challenge traditional process concepts and “push” systems, many... -
Pharmaceutical Quality Management System – Applying the Principles of Lean Documents and Lean Configuration
The Theory of Lean Documents is the product of applying lean principles to the Quality Management System (QMS) documents typically found in regulated industries. Just as lean principles challenge traditional process concepts and “push” systems, many traditional document practices... -
Corrective and Preventive Action (CAPA) utilizing the Principles of Lean Documents and Lean Configuration
Do you find yourself constantly struggling to create, manage, and maintain all of the information found in Corrective and Preventive Actions (CAPA) – which is often redundant, repetitive, and chained together in a cumbersome way? Do you find that... -
ISO 13485:2016 using Lean Principles – Don’t let the New Requirements Surprise You
Medical device designers and manufacturers are required to follow ISO 13485, and will be expected to implement the 2016 revision changes. There is an additional responsibility to ensure that each and every step of the manufacturing process is controlled... -
Pharmaceutical Quality Management System – Applying the Principles of Lean Documents and Lean Configuration
The Theory of Lean Documents is the product of applying lean principles to the Quality Management System (QMS) documents typically found in regulated industries. Just as lean principles challenge traditional process concepts and “push” systems, many traditional document practices... -
Risk Management – Principles of Lean Documents and Lean Configuration
Risk management overarches projects associated with a particular product family, given that risks will both remain and change as new design features and medical indications for use evolve with a particular device. During all phases of a project, any... -
Risk Management using Lean – Are you sure your documents are clutter free?
“The new standard expects you to apply a ‘risk based approach’ to your organization’s QMS processes. The old standard also expected you to think about risk, but only during product realization (in section 7). Now, you’re expected to apply... -
Risk Management – Principles of Lean Documents and Lean Configuration
Description: Risk management overarches projects associated with a particular product family, given that risks will both remain and change as new design features and medical indications for use evolve with a particular device. During all phases of a project,... -
Creating Design History Files (DHF), the Device Master Records (DMR) and the Device History Records (DHR), Utilizing the Principles of Lean Documents and Lean Configuration
Description: The Theory of Lean Documents is the product of applying lean principles to the creation, design, process, and management of controlled documents typically found in regulated industries. Just as lean principles challenge traditional process concepts and “push” systems,... -
21 CFR Part 820 – Quality System Regulation – Applying Principles of Lean Documents and Lean Configuration
Description: All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records. Medical device manufacturing plants, required to follow 21... -
Advanced Course on Lean Documents, Lean Configuration and Document Control for Medical Devices
Description: In this Lean Documents, Lean Configuration, and Document Control training learn the different types of lean documents and the usage of lean document principles; Types of controlled documents; examples of lean and non-lean controlled documents; Pros and cons... -
Corrective and Preventive Action (CAPA) utilizing the Principles of Lean Documents and Lean Configuration
Description: Do you find yourself constantly struggling to create, manage, and maintain all of the information found in Corrective and Preventive Actions (CAPA) – which is often redundant, repetitive, and chained together in a cumbersome way? Do you find... -
Corrective and Preventive Action (CAPA) utilizing the Principles of Lean Documents and Lean Configuration
Description: Design controls involve the translation of user requirements (aka Voice of the Customer) into specific technical requirements as design inputs. These design inputs then form the basis of the design specification, which becomes the design output. Since design... -
21 CFR Part 820 – Quality System Regulation – Applying Principles of Lean Documents and Lean Configuration
Description: Do you find yourself constantly struggling to create, manage, and maintain all of the information found in Corrective and Preventive Actions (CAPA) – which is often redundant, repetitive, and chained together in a cumbersome way? Do you find... -
Medical Devices and Pharmaceutical Quality Management System – Applying the Principles of Lean Documents and Lean Configuration
Description: All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records. Medical device manufacturing plants, required to follow 21... -
Creating Design History Files (DHF), the Device Master Records (DMR) and the Device History Records (DHR), Utilizing the Principles of Lean Documents and Lean Configuration
Description: The Theory of Lean Documents is the product of applying lean principles to the Quality Management System (QMS) documents typically found in regulated industries. Just as lean principles challenge traditional process concepts and “push” systems, many traditional document... -
Design Inputs – Design Outputs Traceability Matrix – Principles of Lean Documents and Lean Configuration
Description: The Theory of Lean Documents is the product of applying lean principles to the creation, design, process, and management of controlled documents typically found in regulated industries. Just as lean principles challenge traditional process concepts and “push” systems,... -
21 CFR Part 820 – Quality System Regulation – Applying Principles of Lean Documents and Lean Configuration
Description: Design controls involve the translation of user requirements (aka Voice of the Customer) into specific technical requirements as design inputs. These design inputs then form the basis of the design specification, which becomes the design output. Since design... -
Pharmaceutical Quality Management System – Applying the Principles of Lean Documents and Lean Configuration
Description: The Theory of Lean Documents is the product of applying lean principles to the Quality Management System (QMS) documents typically found in regulated industries. Just as lean principles challenge traditional process concepts and “push” systems, many traditional document... -
21 CFR Part 820 – Quality System Regulation – Applying Principles of Lean Documents and Lean Configuration
Description: Design controls involve the translation of user requirements (aka Voice of the Customer) into specific technical requirements as design inputs. These design inputs then form the basis of the design specification, which becomes the design output. Since design... -
Risk Management – Principles of Lean Documents and Lean Configuration
Description: Risk management overarches projects associated with a particular product family, given that risks will both remain and change as new design features and medical indications for use evolve with a particular device. During all phases of a project,... -
Design Inputs – Design Outputs Traceability Matrix – Principles of Lean Documents and Lean Configuration
Description: Design controls involve the translation of user requirements (aka Voice of the Customer) into specific technical requirements as design inputs. These design inputs then form the basis of the design specification, which becomes the design output. Since design... -
Creating Design History Files (DHF), the Device Master Records (DMR) and the Device History Records (DHR), Utilizing the Principles of Lean Documents and Lean Configuration
Description: The Theory of Lean Documents is the product of applying lean principles to the creation, design, process, and management of controlled documents typically found in regulated industries. Just as lean principles challenge traditional process concepts and “push” systems,... -
21 CFR Part 820 – Quality System Regulation – Applying Principles of Lean Documents and Lean Configuration
Description: All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records. Medical device manufacturing plants, required to follow 21... -
Advanced Course on Lean Documents, Lean Configuration and Document Control for Medical Devices
Description: In this Lean Documents, Lean Configuration, and Document Control training learn the different types of lean documents and the usage of lean document principles; Types of controlled documents; examples of lean and non-lean controlled documents; Pros and cons... -
Corrective and Preventive Action (CAPA) utilizing the Principles of Lean Documents and Lean Configuration
Description: Do you find yourself constantly struggling to create, manage, and maintain all of the information found in Corrective and Preventive Actions (CAPA) – which is often redundant, repetitive, and chained together in a cumbersome way? Do you find... -
21 CFR Part 820 – Quality System Regulation – Applying Principles of Lean Documents and Lean Configuration
Description: Do you find yourself constantly struggling to create, manage, and maintain all of the information found in Corrective and Preventive Actions (CAPA) – which is often redundant, repetitive, and chained together in a cumbersome way? Do you find... -
Corrective and Preventive Action (CAPA) utilizing the Principles of Lean Documents and Lean Configuration
Description: Design controls involve the translation of user requirements (aka Voice of the Customer) into specific technical requirements as design inputs. These design inputs then form the basis of the design specification, which becomes the design output. Since design... -
Medical Devices and Pharmaceutical Quality Management System – Applying the Principles of Lean Documents and Lean Configuration
Description: All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records. Medical device manufacturing plants, required to follow 21... -
Creating Design History Files (DHF), the Device Master Records (DMR) and the Device History Records (DHR), Utilizing the Principles of Lean Documents and Lean Configuration
Description: The Theory of Lean Documents is the product of applying lean principles to the Quality Management System (QMS) documents typically found in regulated industries. Just as lean principles challenge traditional process concepts and “push” systems, many traditional document... -
Design Inputs – Design Outputs Traceability Matrix – Principles of Lean Documents and Lean Configuration
Description: The Theory of Lean Documents is the product of applying lean principles to the creation, design, process, and management of controlled documents typically found in regulated industries. Just as lean principles challenge traditional process concepts and “push” systems,... -
Pharmaceutical Quality Management System – Applying the Principles of Lean Documents and Lean Configuration
Description: The Theory of Lean Documents is the product of applying lean principles to the Quality Management System (QMS) documents typically found in regulated industries. Just as lean principles challenge traditional process concepts and “push” systems, many traditional document... -
Design Inputs – Design Outputs Traceability Matrix – Principles of Lean Documents and Lean Configuration
Description : Design controls involve the translation of user requirements (aka Voice of the Customer) into specific technical requirements as design inputs. These design inputs then form the basis of the design specification, which becomes the design output. Since... -
Design Inputs – Design Outputs Traceability Matrix – Principles of Lean Documents and Lean Configuration
Description : Design controls involve the translation of user requirements (aka Voice of the Customer) into specific technical requirements as design inputs. These design inputs then form the basis of the design specification, which becomes the design output. Since...