What designs really are ...

Designs are not the device. Designs are the pieces of paper that describes the device. Designs must be recorded on “paper (in your computer) ”. Anything less is just an idea. Ideals can remain in the inventor’s head indefinitely. Only designs that are written down can be produced. When a design is documented, this reduces the dangers that are inherent in vagueness.

 

A development project requires a team of qualified people. Documentation causes the reduction of ideals into words. Documentation forces clarity. Declaring a device into a series of sentences and numbers achieves a significant improvement of the entire body of knowledge associated with the design.

 

Designers must share ideas among other talents such as: electronics, software, mechanics, materials, production designers, etc. Even the most brilliant ideals and shares even the most brilliant designs among the team and allows the design constructs to mature, as farther thoughts and refinements occur. The written records and the descriptions of the design are the only valid method to review the status of the design. In every successful design this documentation is created.  The real issue is not will it be done, but at what stage?

 

The FDA is adamant: you must submit the proper documentation that demonstrates you meet the requirements of Design Controls and Good Manufacturing Practices.

 

The FDA wants YOU to have control. Control must be achieved by documentation. To control the process, the FDA wants you to create enough drawings and instructions about the "manufacturing" of your device to "fill a box".

 

You place these drawings "in a box" and send them to San Diego and send another identical set of drawings to Kansas City (to different vendors who may have different equipment and different training). Both use your drawings and the materials specified to make units for you. The FDA wants to know that these vendors can ship units to different patients t users who may have slightly different clinical needs but all have sufficient information to use these units and achieve results that will all fall into a same statically predicable "bell curve. "

At Compliance Consultants, we are qualified and skilled to create (if desired), appraise, review and qualify engineering documents that may be essential to meet required benchmarks to establish the design is real.

 

The documents we create are real, thorough, and designed to fit your:

• device design,
• engineering development program,
• personnel/training/facility.

 

These are engineering documents created by engineers. We use as a base, only documents that have passed the FDA review on several occasions.

 

Upon completion, these documents serve as valuable tools not only to control quality and product repeatability, but also to lower your unit cost. Our documents not only meet Good Manufacturing Practices, but serve as a launching point for a complete ISO 9001 system.

 

A well designed documentation will:

• establish your product was developed according to standards;

·        verify your product is repeatable batch to batch;

• provide a mechanism to define & record changes to your procedures;
• ensure users can operate your product correctly,
• maintain records to ensure your products can be traced to users.

 

When we visit you, we will present samples of many documents that cover various engineering & manufacturing controls, such as:

 

• Quality Assurance Standards,
• Requirements Specifications,
• Software Definition & Controls,
• Production Specifications,
• Procurement specification,
• Validation Test Procedures,
• Test Data Records (to store results), 
• User Product Support Manuals, and

·        Product Recall & Complaint Handling.

 

 

The FDA views documentation as labeling and considers that labeling is integral to the performance of the product: where if either the product or label is defective -- the same effect occurs to the user.

 

Documents that we create are easy to read, easy to change, highlight critical areas, and are worded plainly to eliminate ambiguities.

 

Since we are technically qualified, we create all documentation on a turn-key basis. We interview, watch, and design documentation to serve your processes. Our documentation supports and enhances the product.  We quote each document as a separate stand alone cost.

 

Contents

We create crystal clear, high performance specifications which are profusely illustrated, clear, and concise. Our documentation follows a special quality formula for consistency:

• artwork, tables and procedures that are easy to follow;
• an economy of white space {all space is filled and all pages are used};
• consistency and presentation of  formal, styled, polished documents;
• consistency and purpose in common names, titles, and procedures;
• document /revision numbers that ensure easy identification and instant location. 

 

As part of this task, you benefit by a disciplined, rigorous, flexible part numbering system that ensures distinction and control. All documents should be archived as both a computer & paper version of all documents.

 

You get useful, simple, complete documents. Our process is a low cost method to create a system of quality and control. This will endure as an investment in your product.

 

Engineering Definition

Since the start of the industrial revolution a specification system is essential to achieve interchangeability and repeatability regardless of the production batch or fabrication vendor. This is fundamental to any medical device. The FDA usually has little to judge your device by - except the quality of your documentation.

 

The early, draft specifications reflect the prototype. As the project matures toward production further product definition is added from improvements derived from testing. The contents of the documents become more accurate while the format becomes more formal. Each specification reflects the growth of knowledge, which defines the parts. When all specifications are assembled, a manageable integrated definition system will be available for both proprietary specifications applications which can be managed and scheduled.

 

Types of engineering documents

System Requirements. This specification defines all major parameter and limitations. All subordinate parameters address and cross-reference these values.   

 

Performance Specification.  Specifies actual quantities, tolerances and limits to be met by the system or component. 

 

Interface Specification. Defines how parts fit together. Applies to custom software as well as a proprietary biological substances. 

 

Component Specification. This defines a “configured item” recognized by a part number (such as an IC or plastic tube). These items are usually stock (or custom designed) from sub-contractors.

 

Procurement Specification. Request for quotation to prospective suppliers covering all aspects including: packaging, shipment, and quantities, etc. 

 

Test Specification. Defines testing that suppliers must meet, such as: methods to select or reject parts.

 

Support Specifications. Defines tools, calibration standards, processes, and procedures to control and remove the uncertainties, which ensure repeatability. 

 

In addition to the specifications there is a host of documents required for test planning, test procedures and test records.