Have you ever signed a document without reading the contents, and had it come back to bite you?

Have you ever bought something that looked good, only to have it break or stop working shortly afterwards?

Have you ever tried to follow a set of instructions only to come away more confused?


If, like us, you have experienced any of these things, then you will appreciate why it is important to get Quality right.

Quality – why it’s important for device development

What do we mean by “quality”? It’s a seemingly simple question, with answers ranging from “it’s what the customer says,” to “conformance with requirements and regulations“.

Quality, in the context of Medical Device Design, is about the final standard of excellence to which the product is made and the path and documentation of the journey taken as the design develops.

Product Design companies and Medical Device Manufacturers are constantly delivering more innovative and complex products, whilst being expected to meet rising quality standards, regulatory compliance and quality metrics.  Robust quality management tools & systems must be in place to ensure regulatory obligations and reporting requirements are met.  To keep pace with these rapid changes, compliance is evolving from an isolated departmental initiative to an enterprise level risk management challenge.

If regulatory bodies find a manufacturer to be non-compliant or in violation of the law, the consequences can be severe.  Sanctions such as warning letters, mandatory product recalls, temporary shut-downs, criminal penalties and fines may be levied, depending on the severity of the violation.

The impact of these sanctions could be crippling to your business.

Therefore it is imperative for product designers and medical device manufacturers to balance compliance with regulations and improve the efficiency of their operations, to protect the bottom line.

Quality and Medical Device Design

standards and regulations compilation

Good Manufacturing Practices (GMPs or cGMPs) form the basis of US FDA’s QS Regulation contained in 21 CFR Part 820 (for medical device manufacturers) and 21 CFR Parts 210 and 211 (for pharmaceutical manufacturers).

Similarly in Europe there are EU wide cGMP regulations (GMP Directives).  In the UK, these are published by MHRA as “the orange guide”.  EU wide Medical Device Directives cover medical device requirements.

There are also ISO Quality Standards applicable to medical device and combination product development, such as ISO 13485 (Design Controls), ISO 14971 (Risk Management) and ISO 62366 (Usability Engineering).  All provide guidance and accepted practices for the designer and manufacturer to follow.

The interpretation of these requirements is often seen as either overly bureaucratic or as just “tick in the box” exercises.  These beliefs are far from reality, where all procedures and records should serve a clear business purpose.

A Quality Management System (QMS) is about sustainability; defining and following a collection of business processes, which form an integral part of your business and ways of working, to repeatedly produce products and services that meet customer wants and needs, whilst complying with regulatory requirements.

Ultimately a QMS must provide clear direction about documenting development stages, a risk management framework and strategy, to demonstrate that the final design of the medical device is safe, efficacious and robust in use and that it meets the needs of the customer.  The final dossier of documents must demonstrate compliance with the regulations of the target market.

Whatever your quality requirements are, from guidance and strategy through to executing and reporting tests, we can help you.


Find out how we can help you, read more about our Quality Management and Quality Auditing services.


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