ERA Technology | Rebound to Safety Engineer

Regulatory Compliance Management & Methodologies

Regulatory Compliance Management and Methodologies (RCMM) services are part of ERA's Safety Engineering services

Latest Update
>	Case Study - Shocking Solutions for the Science Museum - pdf
>	Dealing with Compliance in Complex Situations - pdf
>	Regulatory Compliance Management Course 9 March 2005

Technical regulatory compliance requirements for products and systems apply across the full spectrum of industrial activities, e.g. Commercial, Transport, Aerospace and Defence, and can differ between these sectors, between world economic groups and between countries within and outside those groups.

Real, or even perceived, failure to meet these requirements carries the threat of substantial penalties under criminal law, civil law, contractual requirements or failure to be able to deliver, and ERA Technology can help you to ensure the compliance of your company's products throughout their lifecycle from conception to obsolescence.

The issue is often not "compliance" per-se, but ensuring that the requirements are understood and that the evidence of compliance is available, complete and valid, e.g. for CE Marking - thus "compliance" must be managed like other critical business process.


Meeting the relevant compliance requirements requires an understanding of:
	The regulations and standards requirements that apply in your market sector.
	How those requirements apply to your products, especially where there may be no relevant specific standards, and some of the pitfalls.
	The business units within your company how they can be used to optimise.
	How to integrate the regulatory requirements into the activities of those business units.
	The required evidence of compliance.
	Managing the risks associated with equipment compliance.
	How to deal with the continually changing regulatory environment and its effects on your products over a period of time.


RCMM's services are targeted towards assisting companies in all these critical areas, and in particular we can assist you with:
	Identifying the requirements for your products and systems
	Understanding the overall and detailed implications of these requirements
	Understanding where and how the requirements must be met by relevant departments, general business processes and management of specific projects, e.g.
	"GAP analysis” and audits to determine how existing processes and documentation match up to legal requirements
	Integrating requirements into business processes, devising procedures, and if possible making them common to many projects, thus minimising workloads and costs.
	Integrating requirements into projects using the lifecycle approach, and so ensuring that:
	Compliance is part of project plans
	Specific responsibilities are recognised early on
	Tasks begin at the correct lifecycle stages (Often much earlier than generally appreciated)
	Managing the combined tasks and risks for certification of products to the various regulations for CE Marking and to other requirements (e.g. for the USA or Japan) Applying software applications designed to manage compliance, and providing structured and reasoned arguments that the evidence meets the relevant legal requirements. (Particularly useful where company processes exist but are not linked to compliance programmes, and / or where compliance evidence is in a variety of forms and locations.)
	Reviewing Technical Files and Technical Construction Files for the content, coverage and validity of the evidence

Group staff are experienced in wide ranging national and international requirements, including:
	EU Directives for both CE Marking (e.g. LVD, EMC) and non-CE Marking (e.g. General Product Safety)
	EU and national product safety standards for many types of product
	USA, Canadian and other regional and national regulations and standards
	Equipment and System Regulatory Compliance
	Electromagnetic Compatibility Compliance
	Environmental regulatory requirements for products, including WEEE, RoHS and EUP
	Preparing company processes and procedures for ensuring compliance in programme planning, designing, manufacturing, and field support
	Equipment Product Risk Assessment, including Hazard and Operability Studies (HAZOPS) - which is increasingly part of CE requirements

Training Programmes and Workshops
The group provides training programmes that can be provided either at ERA or in-house, and either directly or through ERA's AccessERA Membership scheme.

When provided, in-house programmes can be customised to address a company’s specific issues for equipment, and can thus provide immediate inputs into relevant processes and projects. Typically these programmes are based around the format shown here in the "Typical Regulatory Compliance Workshop programme - pdf", but they can be adapted to meet your specific current and future requirements.

Contact Information

Tel: +44 (0)1372 367007
	compliance@era.co.uk

Case Studies

A shocking solution for the Science Museum!