Services Available
| Provide guidance and templates for a practical stage-gated product development process, from product concept, through commercialization. |
| Providing a structured approach to ensure that customer, end-user and interested party requirements have been satisfactorily translated into technical requirements, and that these technical requirements are appropriately verified, reviewed, validated and transitioned to design output and design transfer documents. |
| Facilitate the development, organization and implementation of project plans to ensure that appropriate and applicable quality records are created, maintained and and available for regulatory filing. |
| Provide a systematic means to ensure that the project plans and activities are synchronized with product development stage-gated requirements. |
Success Stories
Ron led efforts to establish a stage/phase gated product development process in accordance with U.S. CFR Title 21 Part 820, ISO 13485:2013, ISO 14971:2012, Medical Device Directive (MDD) 93/42/EEC standards and regulations and business requirements for Actamax Surgical Materials, LLC.
Ron successfully led the effort, as a consultant, to simplify and harmonize thirteen (13) product development and design control process of an international medical device company into a single system.
Does a Structured Development Process Help or Stifle Innovation?
In some R&D environments there is a strong belief that procedures and a structured development process hampers the creative process. In a well-designed product development process, there are phases or stages that allow for innovation, such as concept and feasibility.
Requirements & Regulations Enables Creativity
As there are definite design control criteria that must be met, per the U.S. FDA Quality System Regulation (QSR) and ISO 13485:2016, a rigorous framework actually enhances the creative process as well as maintaining design control. Once it can be shown that critical product characteristics can be met, typically at the conclusion of the feasibility stage, they need to be controlled as the product moves through development.
Connecting the Dots
Starting with measurable and clear design inputs, verification and validation plans can be developed to test them in order to create design output documents and design transfer requirements. Think of each design input as a “dot” that must be connected, traced, tracked and controlled throughout the entire development and commercialization process. Ultimately you need to make sure that you made the right product and that you made it per expected and planned requirements.
