Supplier in business of medical device

Types of medical supplier

The general definition of supplier is organisation or person that provides a product, a service or information.

Typical supplier for manufacturer of medical device (IVD) is supplier of components. Do you know supplier could also apply to

External critical process owner as sterilisation, packaging
Outsourced design partner
Original equipment manufacturer (or outsourced production)
External lab - or testing institute
Translation office
Consulting for registration
International distributor

Why is supplier management critical? The professional wording at medical device is safety and effectiveness which is based on all kinds of supplier. Many non-conforming products, troubles at verification or validation, complaints at field, deficiencies of product registration and quality management inspection are caused by non-compliance and often change at supplier (component, service etc.). So this article as well is dedicated to critical supplier for medical device manufacturer.

Applied regulation of medical supplier

Let us scan some popular regulation or guidance how manufacturer should control his supplier:

MDR, article 13, 14, 25, 37
FDA 21 CFR 820.50
ISO 9000, clause 3.3.6
ISO 13485, clause 7.4
MDSAP, chapter 7 - Purchasing
Guidance for notified bodies auditing suppliers to medical device manufacturers

Oft these are ignored:

Regional good manufacturer - or distribution - or laboratory practise
International quality management guidance
International labelling guidance

Related to design and development, registration of medical device

The material, component, service, for sure final medical device can impact safety and effectiveness of final products. More and more authority needs details of critical components (verification) and critical process (validation). Here are some documents mostly asked:

Validation of cleaning room, sterilisation, packaging
Certificate (ISO 13485 or ISO 9001)
Inspection reports during the production
Material management, REACH, ROHS
International wireless certificate if applicable
Compatibility evidence
IFU, datasheet, drawing and bill of material

Related to quality management of medical device

Every manufacturer has his own criterial to select supplier. The key to pass the inspection is to keep Plan-Do-Check-Act in mind. Translated to supplier language is:

Set criteria of suppliers
Selection of suppliers
Evaluation of suppliers
Monitor, measurement and audit of suppliers

Here are some typical documents needed for international quality management application (renewal) or national and international inspection

Design history file
Device master record
Design transfer report
Factory- and floor layout
Employee number, organisation chart
Internal audit, quality manual and management review
List of instrument and machine
Supplier qualification
Supplier procedure

Be ready to control and maintain supplier from manufacturer of medical device

From our best practise, manufacturer should

Update supplier agreement updating medical device and new regulation
Inspect critical suppliers receiving not only quality management certificate but also critical document related
Have regular meeting to talk about troubles and accelerate the communication
Have or outsource a person who speak local language as supplier (especially in Asia)
Transfer regulatory and specification need to inspection scope (regulatory, quality management, design and development and production)

We are regulatory and quality expert. Due to our location in Europe and in China, plus cultural benefit by speaking important European and Asian language, we are keen to qualifying, controlling, maintaining or monitoring your supplier in the field of medical device.