The purpose of production and service provision is to ensure that the manufacturing of your medical device is planned, executed, monitored, and controlled. Essentially, it is to ensure that your product meets defined specifications and that you have the necessary processes and environment for this to happen.

Production controls shall be risk-based. Your product controls shall include drawings, specifications, manufacturing instructions, labeling, packaging, and inspection procedures. The information you defined as part of design and development outputs and as part of your medical device file are essential for product controls.

For each product, you should define product release criteria, including any applicable activities for product delivery and post-delivery. Production controls should also indicate your infrastructure and work environment are appropriately documented and established for manufacturing of your products.

This includes any production monitoring and measuring equipment that might be used. You should have a record of product manufacturing. This record will vary depending on the risk and type of device. For some devices, the record may be an individual, serialized record. For others, the record may be lot-based or batch. In all cases, the production record shall identify quantity of product released for distribution, traceability to the medical device file, and evidence of verification and approval.

Software as a medical device (SaMD)

A note about software as a medical device (SaMD). Yes, it is true that software is not manufactured in a traditional sense. However, these provisions also do absolutely apply to SaMD. Yes, even if your product is 100% software, there will still be a “manufacturer” of the product.

Any device manufacturing when outsourced to other companies, quality check is the responsibility of the medical device company whose name will be on the product. Make sure you have an agreement in place with your CMO that defines quality criteria, roles, and responsibilities. Refer back to the details described in the purchasing section for additional supplier management information.


If your product requires a certain level of cleanliness, this should be defined in a specification. And cleaning processes must be verified and/or validated and monitored.

Cleanliness of product applies if your medical device:

  •  Requires cleaning before use.
  •  Requires cleaning prior to sterilization.
  •  Process agents (e.g. machine oil) are to be removed during manufacturing.


If your medical device requires installation at point of use, then you must define installation requirements and specifications; these items will be part of the medical device file. This includes establishing installation acceptance criteria and provisions to verify correct installation. These should have been captured when defining customer needs and during design and development. Records of installation shall be maintained as part of the product’s records.

Device requires servicing

If your medical device requires servicing, then you must define servicing requirements, specifications, and procedures for doing so; these items are part of the medical device file. Servicing also requires special attention to make sure the device meets its specifications after the product has been serviced. Servicing records shall be documented and maintained as part of the product’s records.


For products that are sterilized and/or have sterile barriers, these processes must be validated prior to implementation. Refer to ISO 11607-1 and 11607-2for specific sterilization requirements.Sterilization criteria should be defined during design and development process. Sterilization process details and results of sterilization validation shall be part of the design and development file and medical device file.

When a production lot or batch is sterilized, records of sterilization shall be documented, traceable to the specific lot/batch, and part of the product’s manufacturing records.


If the output of your manufacturing process cannot be verified, then this process must be properly validated prior to production. The purpose of manufacturing process validation is to demonstrate that the process achieves consistent results and that the product meets defined specifications and acceptance criteria.
Process validation shall include qualification of equipment used in the manufacturing process. Has the equipment been installed properly (IQ)? Does the equipment operate correctly and does the process produce acceptable results (OQ)? Does the process demonstrate long-term stability (PQ)? There are also instances where process validation may apply, even if you can verify the output of your manufacturing process.


You need to be able to identify materials, components, sub-assemblies, and products throughout all stages of the product realization process and their disposition. This includes inventory, work in process, finished goods, distribution, installation, and servicing.
The purpose of identification is to know what products were manufactured and when. Identification records shall be maintained for the product.


Traceability is similar to identification but applicable only after release from manufacturing. Not all medical devices require traceability. However, there are some products that definitely do, such as implantable medical devices. This varies depending on the specific regulations defined for products. When traceability is required, records must be maintained when products are distributed. These traceability records must include name and address of when and where the product was shipped. Traceability helps you know very specific information about where your product is in the event of any pertinent quality events.


In the event you have customer property within your control, you need to have established processes on how to identify, verify, safeguard, and protect this property. You should maintain records of these events. While not widely applicable, an example might be if a customer provides some type of measuring equipment to you to test.


Throughout product realization, you are likely to use a variety of equipment to measure and monitor various aspects of your medical device. Any such equipment must be calibrated or verified to proven standards and criteria so that you know with confidence that the monitoring and measuring data is accurate and precise.

Such equipment shall also be labeled with identification, calibration status, and due date. You should maintain a record of all monitoring and measuring equipment, including calibration details. A good standard to consider for monitoring and measuring equipment is ISO 10012.
In some cases monitoring and measuring equipment may require process validation. This is especially true when software is used as part of monitoring and measuring. Refer to the earlier section on process validation.

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