The Most Important Compliance Best Practices You Need to Know

This document describes:

• the evidence and procedures that may be used by the manufacturer to demonstrate that a medical device is safe and performs as intended by the manufacturer and conforms to the Essential Principles of Safety and Performance for Medical Devices;
• the conformity assessment elements that should apply to each class of device such that the regulatory demands increase with the risk class of the medical device;
• the process by which a RA, or CAB appointed by or acting on behalf of the RA, may confirm that such elements are properly applied by the manufacturer; and
• the manufacturer’s written attestation that it has correctly applied the conformity assessment elements relevant to the classification of the device, i.e. the ‘Declaration of Conformity’.

The definitions and concepts contained within this document are intended to apply to the establishment and maintenance of conformity with the relevant Essential Principles for medical devices generally. Specific guidance will be developed in other documents in relation to in vitro diagnostic devices. Similarly, guidance about how to generate, compile and present clinical evidence for the purpose of demonstrating compliance with the Essential Principles for safety and performance of a medical device will be addressed in future documents.

This document provides guidance to manufacturers and Regulatory Authorities on medical device labelling that clearly informs the user of:

• its identity and intended use/purpose;
• how it should be used, maintained and stored;
• any residual risks, warnings or contra-indications;

Also it promotes

• labelling commensurate with the technical knowledge, experience, education or training of intended users;
• use of symbols.
• the avoidance of prescriptive country-specific requirements for labelling text, content, or the format of labels or labelling that offer no user or patient benefit

Sections:

Definitions
Labelling Requirements
 - General Principles
 - Content of Labelling

This document describes six general requirements of safety and performance that apply to all medical devices.
It provides a comprehensive list of design and manufacturing requirements of safety and performance, some of which are relevant to each medical device. These are grouped as:

• Chemical, physical and biological properties.
• Infection and microbial contamination.
• Manufacturing and environmental properties.
• Devices with a diagnostic or measuring function.
• Protection against radiation.
• Requirements for medical devices connected to or equipped with an energy source.
• Protection against mechanical risks.
• Protection against the risks posed to the patient by supplied energy or substances.
• Protection against the risks posed to the patient for devices for self-testing or selfadministration.
• Information supplied by the manufacturer.
• Performance evaluation including, where appropriate, clinical evaluation

This guidance describes how certain provisions of the medical device Quality System regulation apply to software and the agency’s current approach to evaluating a software validation system.  For example, this document lists elements that are acceptable to the FDA for the validation of software; however, it does not list all of the activities and tasks that must, in all instances, be used to comply with the law.

The scope of this guidance is somewhat broader than the scope of validation in the strictest definition of that term.  Planning, verification, testing, traceability, configuration management, and many other aspects of good software engineering discussed in this guidance are important activities that together help to support a final conclusion that software is validated.

This guidance recommends an integration of software life cycle management and risk management activities.  Based on the intended use and the safety risk associated with the software to be developed, the software developer should determine the specific approach, the combination of techniques to be used, and the level of effort to be applied.   While this guidance does not recommend any specific life cycle model or any specific technique or method, it does recommend that software validation and verification activities be conducted throughout the entire software life cycle.Where the software is developed by someone other than the device manufacturer (e.g., off-the-shelf software) the software developer may not be directly responsible for compliance with FDA regulations.

In that case, the party with regulatory responsibility (i.e., the device manufacturer) needs to assess the adequacy of the off-the-shelf software developer’s activities and determine what additional efforts are needed to establish that the software is validated for the device manufacturer’s intended use.

This guidance applies to:

• Software used as a component, part, or accessory of a medical device;
• Software that is itself a medical device (e.g., blood establishment software);
• Software used in the production of a device (e.g., programmable logic controllers in manufacturing equipment); and
• Software used in implementation of the device manufacturer's quality system (e.g., software that records and maintains the device history record).

Various sections of this Guidance:

• CONTEXT FOR SOFTWARE VALIDATION
• PRINCIPLES OF SOFTWARE VALIDATION
• ACTIVITIES AND TASKS
• VALIDATION OF AUTOMATED PROCESS EQUIPMENT AND QUALITY SYSTEM SOFTWARE

This document supersedes Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued May 29, 1998, and Reviewer Guidance for a Premarket Notification Submission for Blood Establishment Computer Software, issued January 13, 1997.

This guidance document is intended to provide information to industry regarding the documentation that we recommend you include in premarket submissions for software devices, including stand-alone software applications and hardware-based devices that incorporate software.  This document is a result of ongoing efforts to state our recommendations more clearly and ensure they remain current as technology advances.  This document also combines into one guidance recommendations previously included in two guidance documents.

This document is intended to assist medical device manufacturers with the integration of a risk management system or risk management principles and activities into their existing quality management system by providing practical explanations and examples.

A basic understanding of quality management system requirements and a basic knowledge of quality management system terminology are assumed in this guidance document.

This document is based on general principles of a quality management system and general principles of a risk management system and not on any particular standard or regulatory requirement.

This document also:

• Has general applicability to quality management systems for manufacturers providing medical devices;
• Discusses risk management related to medical device safety, rather than financial or other business risks;
• Does not suggest a particular method of implementation; and
• Does not include requirements to be used as the basis of regulatory inspection or certification assessment activities

This compliance guidance is intended to assist companies that develop, manufacture, market, and sell pharmaceutical drugs or biological products (pharmaceutical manufacturers) in developing and implementing internal controls and procedures that promote adherence to applicable statutes, regulations, and requirements of the federal health care programs¹ and in evaluating and, as necessary, refining existing compliance programs.

This guidance provides the OIG’s views on the fundamental elements of pharmaceutical manufacturer compliance programs and principles that each pharmaceutical manufacturer should consider when creating and implementing an effective compliance program
 

The present paper deals with the ambiguity associated with IT outsourcing. Additionally the article, here critically examines the pros and cons of the SaaS system, reminding the regulatory companies to remain ever vigilant on the process of outsourcing.

An establishment inspection is a careful, critical, official examination of a facility to determine its compliance with laws administered by FDA. This Article talks about the different types of FDA inspection, the authority and what are the steps to prepare for FDA inspection. It also shows How FDA Prepares for Inspection, what are the high priority areas of inspection for FDA, the various FDA inspection techniques, close out meeting, post inspection function.
 

Standard CIP-006 is intended to ensure the implementation of a physical security program for the protection of Critical Cyber Assets. Standard CIP-006 should be read as part of a group of standards numbered Standards CIP-002 through CIP-009. Responsible Entities should apply Standards CIP-002 through CIP-009 using reasonable business judgment.

Effective Date: This rule is effective June 6, 2006

The goal of all of the increased Governance, Risk and Compliance (GRC) requirements is to build greater investor confidence in public companies. And to bring back and build greater confidence, build a culture of integrity in internal controls. The article will teach you how you can build a culture of integrity by following a few simple steps.

The goal of all of the increased Governance, Risk and Compliance (GRC) requirements is to build greater investor confidence in public companies. And to bring back and build greater confidence, build a culture of integrity in internal controls. The article will teach you how you can build a culture of integrity by following a few simple steps.

The much criticized AS2 that US companies followed under Sarbanes-Oxley’s Section 404 has finally been replaced by AS5. But, is this replacement going to improve the scenario? Let’s explore the new standard and compare it with AS2 for a better understanding.

EuroSox is the EU directives which came into force from 2008/9. Through implementing the directives, company can develop a strategic opportunity to control the regulatory parameters. The present article details the components or regulatory vehicles of the EuroSox which aim to restore investor confidence in the EU.

Compliance provides added value in a corporation and builds the company's brand, competition and reputation. With proper implementation and monitoring of compliance, risk assessment, improvement of internal controls and reporting standards and mechanisms, ensuring security of IT information becomes improved. Therefore, one should learn the tools of evaluating efficiency of ethics and compliance projects and the Self assessment and Evaluation tool is just the right kind of tool that will help implement Compliance activities in your company.

Improved Corporate Governance policies help improve relationships among the many stakeholders involved and also help reach goals for which the corporation is governed. Being cognizant of the significance of Corporate Governance policies, the present article provides its readers with an amazing 10 step self evaluation tool in order to improve corporate government policies.
 

Has the recent global crisis resulted from GRC flaws? Or is it the board members and regulators who failed to implement and monitor GRC properly? The present article promises to let its readers know more about the weaknesses of the GRC and provides a concise framework for embedding robust board governance with simple to follow action items that are essential to improving corporate governance, sustaining a high level of confidence by all stakeholders, preventing the disastrous ethical and moral lapses that forced a series of regulatory reforms, and in some cases very expensive over-reactions. In a nutshell, the article attempts to provide ‘solutions’ to a series of current GRC concerns related to The Board members and their GRC areas of responsibilities, which the Board should fully understand in 2010.

U.S. Department of Health and Human Services Secretary Kathleen Sebelius on April 6, 2010 had delivered in a speech titled “Health Reform and You: How the New Law Will Increase Your Health Security”. From the title of the speech subject is quite understandably becomes clear to the reader, and yes, the topic of her speech was the newly passed healthcare bill, famously known as Obamacare bill and infamously, The Affordable Care Act.

The recent healthcare reforms law by President Obama includes provision to decrease substantial taxpayer subsidies to private insurance companies that administer Medicare Advantage plans. This can be achieved by strengthening oversight, improving efficiency and tough provider screening which enable to identify fraud at the initial stages.