MODULE-4

purchasing overview (clause 7.4):

 controls are maintained in the supply chain to ensure that conforming medical devices
delivered through supply chain

 Product should be evaluated and conformed by the manufacture team and vendor must have a
knowledge before purchasing the product, it must be verified and iso certified with regulatory
requirements.

Vendor evaluation and performance (clause 7.4.1):

 The vendor must be ISO 9001 certified with regulatory requirements before producing the
products and services to the medical industry.
 Vendors evaluated and selected based on their ability to meet requirements from the buying
company.
 The vendor should be strictly evaluated, and the software validated before approval for this type
of product.
 Communication takes place between vendor and buyer while purchasing products, to address
any non-conformances or missed expectations.

Categories of certified vendors:

Approved: status for vendors that are approved.

Probation: for new vendors still under evaluation or vendors placed on prohibition due to poor
performance.
Disqualified: for vendors who we cannot buy from for repeated performance or who can no longer
supply the product specified.

Purchasing information and verification of products (clause 7.4.2 & 7.4.3):

 For vendor specification the buying company should need to provide clear understanding
expectations and requirements.
 The requirements of purchasing will include the QMS controls for vendors, vendor requirements
are specified through vendor agreements on buying websites.
 Companies make internal modifications; employee positional & equipment changes on a regular
basis it impacts on buying products before changing we must inform to the buying vendors and
take agreement.

Production and servicer provision overview (clause 7.5.1):

 Production and service provision are the nuts and bolts of physically making the product and
performing an service and these activities should have necessary controls in place to conform a
productivity.
 A service must be provided that meets the requirements and specifications of the customer.
 Medical device companies will need to consider specific elements for product and service
provision

Qualification of your infrastructure (clause 7.5.3 and 7.5.6):

Here, we see about infrastructure qualification and what are the controls we put in place, loke
cleanroom protocols, equipment qualifications, temperature controls, software.

Equipment measuring devices, software, and employee should be qualified before making or servicing
medical devices
Validation f process (clause 7.5.6 and 7.5.7):

 Validating the production and service provision processes are stable, these includes production,
inspection, testing, labeling, packaging product release, delivery, and post-delivery.
 Validation is for processes what qualification is for equipment people; validation provides a
documented record that process is capable and operating consistently.
 Special validation process: SVP in the medical device industry is required when you cannot
confirm the output of the process through normal monitoring and measurement practices and
need an alternative method of validating the desired result.

Labeling and packing (clause 7.5.11):

 Labeling it is an critical component of a medical device because it provides important

information regarding the device like, identification, safety or storage codes, installation,
servicing and maintenance information.
 Labels are used for devices to be safe and effective to use.
 ISO 15223- it is an international standard that provides symbols that can be used with medical
device, labels, labeling and information.
 ISO 11607 packing for terminally sterilized medical devices.
 ASTM(American Standards for Testing and Material).
 F1585 guide for INTEGRITY TESTING of porous medical packages.

Cleanliness of products (clause 7.5.2 and 7.5.5):

 Medical cleanliness should require high degree of cleaning of protocols to safeguard patients
that are impacted by the device.
 It is sometimes difficult to detect tiny particulates in the devices that could make their way into
a human being with severe consequences.
 Your company must document monitoring mechanism and controls to prevent any form of
contamination and ultimately protect users.
 Protocols must be developed to ensure that particles and contaminates are not introduce in any
form.