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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.

Are you medical supplier? We can suggest you or even cooperate with you for matching manufacturer.

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