Medical Devices
Medical device companies encounter several challenges to successfully deliver innovative and reliable products while complying with MDR, FDA and ISO quality system regulations. Paper-based systems and traditional file-centric document management tools fail to provide the full design record and at the same time slows the pace of development. Highstage allows the organisation to act faster by getting full control over all relevant documentation as it is produced during the development project. Highstage will also enable full product lifecycle management, including post market activities, IoT and change management.
Talk to usUNEEG has got a steel grip on their technical files
Uneeg uses Highstage accross their development project. Their regulatory team use the Document module to manage all files and documents related to their various technical files (DHF, DMR, etc.).
Documents are electronically signed by reviewers and approvers according to FDA CFR Part 11 requirements.
Highstage references are used to manage which revision of the technical file documents are the correct and valid ones, utilizing the Refence Lock functionality, to lock in a revision to the DHF, even if there exists newer versions.
Read more about Uneeg's unique long term EEG-monitoring here.
I just love references!!Nita Volder Hansen, Process Engineer
Perfect for medical devices
Highstage has supported medical device companies for years, offering features saving time while improving regulatory work.
FDA CFR Part 11
Highstage is compatible with FDA CFR Part 11, and provides traceability and electronic signatures accordingly. All documents, drawings and other files are managed by version/revision, and are signed for authoring, review and approval electronically. Each person is signing for his/hers capacity, and signatures cannot be tampered with.
All versions/revisions are stored and protected from being altered. In addition, a comprehensive eventlog is documenting all events to any metadata.
Integrating BOM and tech. files
Version locked references is the clue to getting 100% control with Highstage. If you manage your product BOM (Bill of Material) in Highstage, and your technical files, making them integrated in a common context is a breeze.
Refer to relevant technical documents from a BOM Component (Part), og vice versa. Make sure the reference is locked to a version of the parent and a version of the part, and you simply can't make accidental changes without noticing.
As a result, you can navigate to your technical files from your BOM or BOM components, or to your components from your technical files.
Structured product release
With the Highstage PART module, your product release process is automatically structured and streamlined.
Again, references play a key role. Build your BOM Structure as deep and advanced as necessary, and make sure to use reference locks. References mandates that you approve/release the children prior to approving the parent. In this way, a bottom-up approval process is deployed, ensuring that components are approved prior to sub-assemblies, main assemblies, etc.
The product can then only be released when the hole assembly is approved.
If technical files are referenced from BOM Components, the product will not be released until all technical file documents are approved, which will ensure a concurrent approval of the product and its documentation.
Medical Device focus areas
How can Highstage help your medical device company
Compliance
Highstage will help you with both company compliance (ISO 13485, etc.) and product compliance (MDD/MDR/FDA/MDSAP/etc. - more on this under the Tech files tab).
The first step of company compliance is to manage and distribute all QMS (Quality Management System) and SOP's (Standard Operating Procedures).
The next step, is to manage all technical files, controlled by audit trails and electronic signatures according to Part 11.
At a higher level, critical company processes can be deployed using the Highstage Action module. Processes like Design Change, Product Development, Customer Complaints, etc. can be modelled in Highstage, and one instance is spawned per new activity. This gives guidance to the users, and increases employee adherence to policies and SOP's.
The next audit should be heartly welcomed.
Read more about the Action Module
Technical files
If your organization is still printing and signing technical files, building manual DHF, DMR, etc., there is a new world of efficiency and control waiting for you.
In Highstage, every document type is allocated to a chapter/section in your DHF/DMR/etc. Every time you create a new document, it will be automatically inserted into the DHF/DMR/etc. for the relevant project. Consequently, all engineers are automatically building he DHF/DMR/etc. every time the create a new document.
This is a new world in simplicity.
For the regulatory manager, it is simply a matter of determining which version of the document which is relevant for each release of the product, and monitor the progress of all the documents.
Read more about the Document Module
Compiled automatic reports
No more tiresome work maintaining DHF/DMR indexes. No more errors maintaining DHF/DMR indexes.
Instead, let the references in Highstage do the job for you.
Any Office document can be set up to automatically generate the content based on the references. It can be set up to produce list of tech file document section by section, with all the metadata you require included.
Safe signatures
Safe signatures is a standard feature in Highstage. For medical device applications, they can even be enforced to adhere to FDA CFR Part 11.
When a document is signed off by author, reviewer or approver, Highstage will require the user to prompt his/her password, and define in which capacity (product manager, project manager, quality manager, CEO, etc.) he/she is signing as.
Signatures cannot be tampered with. They can be automatically printed to the document front page.
Read more about the Document Module
Tracability
Highstage has an extensive audit trail. All operations done on any metadata throughout the system is recorded in the eventlog.
The eventlog stores information on when, and by whom, and operation was done. From altering a value to approving a part or document.
Highstage has also got a word compare feature, that compares content of MS Word documents. Nice feature to see changes from version to version.
Document Map
Gain full control over your project by setting up a complete or partial document map for the product under development. Create all planned documents, and reference them in a document hieararchy.
During the project, you have full control over the progress just by monitoring the status of the documents in the document map.
Technical files are building themselves in parallel.
Want to know more?
For more information about Highstage in Medical Device applications, please contact Per Reidar Ørke.
Send him a mail here.
Medical Device User Consortium
Highstage has taken an initiative to gather regulatory/QA resources from our medical device customer regularly. Every second month, we meet, discuss and share solutions. Challenges are basically the same, and it provides value to the users and to Highstage to discuss and share challenges and experiences. New customers are welcome to join the consortium. Contact Per Reidar Ørke to learn more about the consortium.
Resources
You are more than welcome to contact our main office. But if more convenient, please contact one of these local partners.
Sweden: Maxiom Flow
Rolf Gustafsson:
+46(0)709 17 44 80
rolf@mflow.se
Norway: PROfolio
Contact Per Reidar Ørke:
+47 909 76 415
pro@profolio.no