Regulatory Compliance


Many companies operate within a highly regulated, constrained, customer led environment and the activity of creating the breakthrough ideas necessary is both conceptually and practically difficult to implement.

Manufacturers of medical devices will only succeed in today''s global economy if they use innovation as an essential element of their business strategy spanning the entire business product life cycle from marketing, manufacturing and product disposal. CLM Training has the expertise to support you.

Sometimes Business Objectives may require only the minimum regulatory requirements to be met, in order to place products on the market. At other times a strong Business Improvement approach may be required.

CLM Compliance Experience

CLM Training specialists can help you decide the most appropriate option. All Compliance Strategies consist of both a Quality System / Quality Principles component and a Technical File. The Technical File addresses the product Safety and Performance aspects, whilst the Quality System controls all documentation and records to ensure processes are effective and efficient and that Regulatory requirements may be demonstrated.

Leadership, management skills, risk management and communication processes form an essential element of both achieving and maintaining regulatory compliance.

All of CLM's client engagements are backed up by a detailed, costed proposal.  Call or email us now for a confidential discussion .