Medical device safety with CRC
With CRC, your medical products are in safe hands: From MDR/IVDR-compliant documentation to qualification and validation, we provide comprehensive support in the creation and maintenance of your technical documentation, allowing you to focus on your core business.
Documentation
according to MDD / MDR IVDD / IVDR
Q & V
Support in Qualification and Validation
Updates
and maintenance of technical documentation
Creation of
MDR-/IVDR compliant documentation
Regardless of the various terms for the technical documentation of medical devices (Product Master File, Medical Device File, documentation for CE marking, DMR (Device Master Record), Technical File, STED), this documentation includes information on:
- Product description / intended use / intended purpose / indications / side effects / contraindications
- List of items that can be used in combination / Description of the interfaces
- Classification
- Instructions for Use / Package Insert / Product Labeling
- Checklist of Essential Requirements / List of Applied Standards
- Risk management document
- Technical Data / Drawings / Specifications / Parts Lists
- Manufacturing instructions and work plans / Inspection instructions
- Verification and validation protocols in the context of development
- Packaging specifications
- Clinical trial / Evidence of efficacy
- Usability
We are happy to provide you with advisory support for the creation of the content of these documents. To assist with peak loads in projects, the competent experts from our team will take over the completion of defined work packages.
- Examination of the application area and the deployment environment
- Review of the basic requirements
- Product classification
We have many years of experience in standards research, including the consideration of harmonized standards. For conducting the research, we have developed efficient methods based on solid knowledge.
We support and advise you in reviewing the standard requirements and help you develop an understanding of the relevant terms related to risk analyses and create the corresponding documentation.
We assist you in establishing a vigilance system according to REGULATION (EU) 2017/745 and related accompanying documentation.
We create user manuals for you that meet the requirements of the MDR. This allows your customers to handle your medical products as safely as possible, while also achieving a liability-safe position for your company. Your individual needs and those of your customers guide us in creating a customized user manual.
We support you in the preparatory measures (planning, setup, and clarification of requirements) for your product tests. Furthermore, we assist you in the execution, documentation, and evaluation of the tests to meet the requirements according to MDR (EU).
Implementation of
Qualification and Validation
As part of the conformity assessment, it is required that, in addition to the development of a safe product, its manufacturing must take place in controlled processes. For this, preparatory and production-related activities are necessary to achieve valid processes:
- Specify production equipment (create requirements specifications / functional specifications)
- Acceptance tests of production machines (FAT / SAT)
- Conduct process risk analyses (PFMEA)
- Define critical components
- Create process control plans
- Create maintenance instructions
- Create calibration instructions
- Establishing Statistical Process Controls (SPC)
- Define test methods
Conduct qualifications / validations
- Specification Qualification (SQ)
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operation Qualification (OQ)
- Performance Qualification (PQ)
- Maintenance Qualification (MQ)
We are happy to assist you in creating the content of these documents. To support during peak workloads in projects, the competent experts from our team will take over the completion of defined work packages.
We are happy to assist you in the development of your manufacturing process, including the definition of process parameters. This applies to both the planning and the execution of necessary experiments to capture the interactions of parameters.
CRC feels at home with the Machinery Directive. We support you in assessing your machine to meet the complex requirements of the Machinery Directive. Thanks to the various disciplines, we form a strong team of problem solvers.
We support you in implementing regulatory requirements. Additionally, we offer training to help you understand the requirements and structure of the Machinery Directive and to enhance the efficiency of your machine designs.
After the DQ has ensured that the correct machine/system has been developed or procured, the installation qualification is used to verify whether what has been delivered and installed meets the specifications. We are happy to assist you in planning and executing the IQ.
Upon completion of the IQ, it must be demonstrated that the functional performance of the procured machine/system meets the specifications. It is important to plan and conduct the tests in such a way that the evidence can be provided with minimal effort. By this time, the procedures or work instructions for the maintenance and care of the machine/system should already be available. We are happy to create these documents for you, as well as the OQ plans and OQ reports, and we can also carry out the necessary tests for you upon request.
In conclusion, it is necessary to demonstrate that the machine/system consistently produces products of uniformly high quality. A statistically representative proof must be provided through a corresponding number of produced samples that the machine/system meets the requirements for later actual operation. We are happy to assist you in planning and conducting the PQ as well as in creating the resulting PQ reports.
Creation of Manufacturing Documentation
It is a regulatory requirement and makes sense to maintain control over processes at all times when manufacturing medical devices. From the purchase of raw materials to storage, manufacturing, packaging, and shipping, we develop and document the following for you:
- Raw material specifications
- Material specifications
- Incoming goods inspections
- Storage specifications
- Manufacturing specifications
- Test specifications
- Cleaning specifications
- Maintenance Instructions
- Setup Instructions
- Calibration instructions
- Hygiene Plans / Pest Control
- Lock regulations
- Control of environmental conditions
We create the content based on your company's size and structures in a way that the documents can be trained and lived. Our goal is to describe the essential aspects clearly and understandably, thereby increasing the usefulness of the documents.
We create complete documentation for you to ensure safe and controlled manufacturing of your products. With a solid knowledge of production techniques and many years of experience, we can offer you customized documentation from the beginning to the end of the process, describing all important process parameters, explaining the setup and adjustment of the machines, and ensuring regular maintenance of the machines.
To define and test incoming raw or semi-finished materials, we create the necessary specifications and thereby establish defined acceptance criteria to ensure consistent quality of your products.
For quality-relevant inspections of your products, we develop suitable methodologies together with you and create the necessary documentation for this.
Update and maintenance of
Technical Documentation
Whether adjustments to your product documentation are required to meet the requirements of the MDR / IVDR, updates due to new revisions of harmonized standards such as ISO 14971 / ISO 62304 / ISO 62366, changes to your product portfolio, or adjustments due to entry into new markets, we are happy to provide a competent team for the processing. Our goal is to enable you to focus on your core business.
We will determine the changed requirements for you and create a gap analysis to identify the necessary work packages, and we will provide binding support in their execution.