Originally Published IVD Technology October 2004
In this section
1. Clinical research, specimen procurement services design and conduct clinical trials and field studies, and provide specimens to be used in product evaluation.
2. Laboratory research services provide diverse forms of laboratory support, including analytical testing, specialized product and process development, and materials characterization and evaluation.
3. Legal affairs consultants offer a wide range of support services, including work on intellectual property issues, contracts, regulations, and general business law.
4. Liability insurance firms specialize in advising client companies about their liability insurance needs, including those related to clinical testing of new products.
5. Market research services can provide valuable information throughout the entire product life cycle. Their focus is to identify, quantify, and evaluate emerging product markets, and to track changes in markets as they mature.
6. Marketing, distribution services are provided by specialists with expertise in marketing techniques and distribution logistics, often including just-in-time delivery arrangements.
7. Packaging and labeling consultants can provide help with package design, automation of packaging and labeling processes, and package testing for conformity to manufacturer specifications. Labeling specialists can also help ensure that product labeling meets regulatory requirements, including the language requirements of the European Union's member states.
8. Patenting consultants can write and submit patents, evaluate existing patents to prevent infringement and determine if licensing is necessary, and evaluate product and process designs to determine the status of intellectual properties.
9. Personnel recruitment experts are used to locate, qualify, and hire acceptable candidates.
10. Process development and validation consultants specialize in the design, development, qualification, and validation of manufacturing, packaging, inspection, and testing processes.
11. Product R&D and design consultants specialize in design of products and associated processes, often using advanced software systems such as CAD/CAM. Consulting firms in this area are often certified to the ISO 9001 quality standard.
12. Product testing consultants represent a wide range of testing services for complete or partial testing of raw materials, work-in-process components, final products, or packaging systems.
13. Quality systems certification is performed by organizations certified by accreditors as having the knowledge, skill, and experience to evaluate a company's quality system against the ISO 9000 family of quality standards. Companies pursuing ISO 9000 certification must employ one of these organizations.
14. Regulatory affairs consultants advise companies on their relationships with regulatory agencies, write premarket submissions, manage the product approval process, interpret regulations, and provide answers to specific regulatory questions.
15. Site selection and facility design consultants can identify potential sites for business expansion, locate facilities, negotiate leases, provide direction about building codes and permits, and design and manage the construction of facilities (including specialized facilities such as biocontainment areas or cleanrooms).
16. Software design and programming consultants work from requirements specifications to write software programs that operate instruments, control processes, or change existing software to meet an identified need.
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