SOPs for Medical Devices

Design transfer activities during the design and development process ensure that design and development outputs are verified as suitable for manufacturing before becoming final product specification. This Standard Operating Procedure (SOP) for the medical devices design transfer is ready to use and meets expectations of 21 CFR 820 for the transfer from development to manufacturing. The 9-page SOP only needs some minor modification before it can be used by your company as the basis for a successful design transfer in the overall scope of design control.

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This Medical Devices Development Plan describes in detail all essential steps to be considered prior to start the development of medical devices and is in alignment with current FDA and EMA expectations.

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This Standard Operating Procedure (SOP) describes in detail all the key steps to implement for a consistent, reliable and effective Hazard Analysis Program. This program is a requirement by the agencies not mattering if FDA or EMA. It is essential to identify, mitigate and control risks associated with the development of medical devices.

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This Standard Operating Procedure (SOP) describes the program necessary for the Corrective and Preventive Action (CAPA) Program. The purpose of this document is to provide clear guidance for Quality and personnel working in a GMP environment when conducting CAPAs. The CAPA system in addition assures the tracking and trending of actions and issues requiring mid-term and long-term corrective actions. This procedure will provide guidance on the requirements and the use of the system as well as the procedure for processing CAPAs.

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This Standard Operating Procedure (SOP) describes the program necessary when conducting the Annual Product Review (APR) which must be performed for each commercial product. The purpose of this SOP is to provide clear guidance on how to perform an APR with the purpose to verify the consistency of the process, to assess trends, to determine the need for changes in specifications, production, manufacturing, and/or control procedures and to evaluate the need for revalidation.

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This Standard Operating Procedure (SOP) describes the program necessary to assure compliance with all relevant GMP and Regulatory Requirement. Therefore this SOP defines the procedure and responsibility for the Internal Audit (Self-inspection) planning, implementation and follow-up to assure Site’s compliance with regulatory, cGMP and Site quality procedures.

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This Standard Operating Procedure (SOP) describes the Training program for Company personnel to acquire the skills, knowledge and qualifications necessary to perform effectively the duties and tasks for which they are employed.

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This Standard Operating Procedure (SOP) describes the Process on how to write SOPs. Standard Operating Procedures (SOPs) must be written, approved and followed for any routine operation, activity or task that may impact the safety, quality, purity and efficacy or distribution of active pharmaceutical ingredient, pharmaceutical product (i.e. drug product) or medical devices to ensure consistent application and meet regulatory compliance. The purpose of this Standard Operating Procedure (SOP) is to standardize and systematize the creation, revising, approving and issuing of Standard Operating Procedures.

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This Standard Operating Procedure (SOP) describes the Process on how to manage the Preventive Maintenance Program. The SOP describes the processes for requesting, conducting and managing the overall Preventive Maintenance (PM) activities.

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This Standard Operating Procedure (SOP) defines and describes the Management Review process, to monitor and verify the implementation of the Management System.

This assures the sustainability, suitability and effectiveness of the whole Quality Management System for medical devices and its compliance to satisfy ISO 13485 and 21CFR 820.

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This Standard Operating Procedure (SOP) describes the individual steps and process necessary to comply with the Clinical Evaluation for medical devices. This SOP applies to all Medical Devices under development after concept and feasibility studies are completed.

Demonstration of conformity is requested by the Council Directive 93/42/ECC, Annex I, with the relevant essential requirements, which include a clinical evaluation in accordance with Annex X.

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This Medical Device SOP Package contains the most important SOPs of a Medical Device Quality System.

The package consists out of 17 standard operating procedures and related forms.

All templates are immediately downloadable after payment as Microsoft Word files and after personalization ready for implementation.

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This Standard Operating Procedure (SOP) describes in detail all the key steps to implement an reliable and effective Risk Management Program. This program is a requirement by the agencies not mattering if FDA or EMA. It is essential to identify, mitigate and control risks associated with the development medical devices.

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This procedure pertains to GMP related Audits of suppliers of raw materials, excipients or components, drug products, drug substances and medical devices, contract manufacturing and services, contract laboratory testing, contract packaging or labeling facilities. All of these service providers are called in the SOP “suppliers”. Learn More

This Standard Operating Procedure (SOP) is ready to use and meets expectations of 21 CFR 820 for establishing a structured Design History File (DHF). The 8-page SOP only needs some minor modification before it can be used as the backbone of the documentation needed during design control.

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This Design Control Standard Operating Procedure (SOP) is ready to use and meets the expectations of a structured development by guiding the design efforts through well defined input and output phases. The 11-page SOP only needs some minor manufacture or design center specific modification before it can be used for your development.

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Are you in compliance with the 21 CFR 820 requirements? This check list can be used to identify gaps in your Quality Systems. The checklist is guiding you with relevant questions through all sections and requirements of the 820. It can be used as internal audit aid or as a questionnaire for external suppliers and contractors.

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This Standard Operating Procedure (SOP) describes the Design Input which is part of the Design Control process by which the activities associated with the planning, design, and development of a new medical device are controlled and documented.

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This Standard Operating Procedure (SOP) describes the procedures for documenting the Design Outputs corresponding to each Design Input for Product development within the Design Control process. This will also allow for planning of the Verification of the Outputs.

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