CE Marking: The mark that may be applied to a product to demonstrate that it conforms to the requirements of a European Directive. The CE marking must be applied to all medical devices sold within the EU to demonstrate that the device conforms to the essential requirements of the MDD.

Controlled Documents: All internally generated documents that have been designated as pertaining to the operation of its quality management system. These include all: policies, procedures, work instructions, records, job descriptions, and organizational charts. Externally generated documents that have been designated as impacting upon the operation of its quality management system or affecting product quality. These include: relevant ISO, EN, ANSI and other standards, relevant medical devices regulations, and client–supplied product specifications, drawings, and instructions.

Clinical Trial: is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials (also called medical research and research studies) are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. Trials are in four phases: Phase I tests a new drug or treatment in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people; and Phase IV takes place after the drug or treatment has been licensed and marketed.

Clinical Trial Types: The NIH organizes trials into five (5) different types: (a) Treatment trials: test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy; (b) Prevention trials: look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vitamins, vaccines, minerals, or lifestyle changes; (c) Diagnostic trials: conducted to find better tests or procedures for diagnosing a particular disease or condition; (d) Screening trials: test the best way to detect certain diseases or health conditions and; (e) Quality of Life: trials (or Supportive Care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness.

Clinical Trial Design:Trials may be designed to assess the safety and efficacy of an experimental therapy, to assess whether the new intervention is better than standard therapy, or to compare the efficacy of two standard or marketed interventions. The trial objectives and design are usually documented in a clinical trial protocol.

Directive 91/356: regulation defining the information to be contained on labels including:  Sponsor’s name and contact details; Pharmaceutical dosage; form of the drug; Route of administration; Quantity of dosage units; Name/identifier and strength/potency (open trials only); Batch and/or code number to identify contents and packaging; Trial reference code identifying trial, site, investigator and sponsor; The name of the investigator; Directions for use; Storage conditions; Period of use in clear month/year format; Keep out of reach of children.

Good Clinical Practice (GCP): International quality standard provided by the International Conference on Harmonisation (ICH) that defines standards, which governments can transpose into regulations for clinical trials involving human subjects. The guidelines define the standards which trials are conducted including the roles and responsibilities of clinical trial sponsors, clinical research investigators, and monitors. They also include protection of human rights as a subject in clinical trial as well as provide assurance of the safety and efficacy of the newly developed compounds.

Good Distribution Practice: (GDP) Guidelines for the proper distribution of medicinal products for human use. GDP is a quality warranty system, which includes requirements for purchase, receiving, storage and export of drugs, intended for human consumption. GDP regulates the division and movement of pharmaceutical products from the premises of the manufacturer of medicinal products, or another central point, to the end user thereof, or to an intermediate point by means of various transport methods, via various storage and/or health establishments.

Health Level Seven (HL7): An all-volunteer, not-for-profit organization involved in development of international healthcare standards. “HL7” is also used to refer to some of the specific standards created by the organization (i.e. HL7 v2.x, v3.0, HL7 RIM etc.). HL7’s primary mission is to create flexible, low-cost standards, guidelines, and methodologies to enable the exchange and interoperability of electronic health records.

ISO 9000:2000: The International Organization for Standardization models for quality assurance. ISO 900:2000 is the model for design, development, production, and installation and servicing.

ISO 13485:1996 and ISO 13488:1996 Standards: The International Organization for Standardization's particular requirements for suppliers of medical devices that is more specific than ISO 9001 and ISO 9002, respectively. ISO 13485 represents a model for quality assurance in design, development, production, installation and servicing. ISO 13488 covers all of the foregoing except design. ISO 13485 and ISO 13488 should be applied in conjunction with the ISO 9001:1994 and ISO 9002:1994, respectively. These are not stand-alone standards. The European version of ISO 13485 and ISO 13488 is EN ISO 13485 and EN ISO 13488 respectively.

ISO 13485:2003: ISO 13485:2003 Medical devices – Quality management systems:  Requirements for regulatory purposes replaces ISO 13485:1996 and ISO 13488:1996. This is a stand-alone standard, modelled on ISO 9001:2000, but does not require continual improvement or customer satisfaction.

Medical Device: Any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of: (a) Diagnosis, prevention, monitoring, treatment or alleviation of disease; (b) Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap; Investigation, replacement or modification of the anatomy or of a physiological process and: (c) Control of conception which does not achieve its principle intended action in or on the human body by pharmacological; immunological or metabolic means, but which may be assisted in its function by such means.

Technical Documentation: Information on each product relating to: classification, description, intended use— including use with other devices, performance characteristics, evidence that all safety and effectiveness requirements for the various regulatory jurisdictions have been satisfied, harmonized standards used, key documents that demonstrate product conformance, risk analysis, clinical data, quality system approval, product approvals and all associated documents.

21 CFR Part 11: Section of the Code of Federal Regulations that deals with the FDA guidelines on electronic records and electronic signatures in the United States. Part 11 as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records. Practically speaking, Part 11 requires drug makers, medical device manufacturers, biotech companies, biologics developers, and other FDA-regulated industries (not including food manufacturers) to implement controls, including audits, validation systems, and documentation for software and systems involved in processing many forms of data as part of business operations and product development.