Who is it for?
It is specifically for organisations involved in any of the following processes: design, development, production, installation, and servicing of medical devices.
Which package is right for me?
LFH recognise that some clients do not have available resources for regulatory support, so they like the option to write their own QMS. This is why we have provided a suite of packages to choose from, whatever stage you are at.
Dr Yupei Xiao
We understand that you will not want to risk purchasing a set of templates, only to find that they are not ‘fit for your purpose’, so we e-meet you to discuss your needs, to ensure that you have chosen correctly.
Each package comes with four hours of guidance from a qualified quality consultant to assist you in tailoring your package.
Select a package to see the content and to purchase.
The initial stages of product development and production
£5000
We also offer individual and bespoke procedure sets. Please get in touch to let us know what you would like.
We recognise the critical importance of your QMS to your organisation, customers, patients, and regulatory agencies.
Whether you are navigating the complex UK and European markets or expanding your reach globally, our QMS expertise is tailored to meet your specific needs.
Clinical and performance evaluations are a vital step in validating the safety and efficacy of your medical devices or IVDs.
Understanding Medical Device and In Vitro Diagnostic (IVD) regulations is complex and requires a comprehensive understanding of the entire product lifecycle.
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Simplify your path to compliance, reach out to our experts today!
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Each procedure template is designed to meet industry standards, along
with guidance notes and relevant associated forms.
Once you have received your QMS package, we’ll organise a convenient
time to e-meet you to guide you through the customisation of your
templates to meet your specific business needs.
Additionally, all QMS packages will include a consultation session of four
hours to support you in the construction of your QMS.
Absolutely. The templates are editable and come in MS Word format.
We always keep up to date with the latest regulatory requirements;
therefore, the templates will be valid at the time of purchase.
We can provide ongoing support. If you have questions or need further
guidance, feel free to contact our support team: we’ll be happy to assist.
Please email us: info@lfhregulatory.co.uk or call +44 (0)1484 662575
Yes, we offer custom template creation services. If you have specific
requirements that are not covered by our existing templates, please let us know, and we can discuss a custom solution. Please email us: info@lfhregulatory.co.uk or call +44 (0)1484 662575
|
Early Phase | Virtual Manufacturer | Full QMS | MDR/IVDR Templates |
|---|---|---|---|---|
| Procedure | ISO 13485 | ISO 13485 | ISO 13485 | ISO 13485 |
| Acceptance Activities Procedure | ||||
| Change Control Procedure | ||||
| Classification and Conformity Assessment Procedure | ||||
| Clinical Evaluation Procedure | ||||
| Complaint Handling Procedure | ||||
| Corrective and Preventive Actions (CAPA) | ||||
| Customer Feedback Procedure | ||||
| Customer Property Procedure | ||||
| Design and Development Procedure | ||||
| Document and Record Control Procedure | ||||
| Economic Operators Procedure | ||||
| Field Safety Corrective Action and Field Safety Notice Procedure | ||||
| Human Resources and Training Procedure | ||||
| Identification and Traceability Procedure | ||||
| Infrastructure, Work Environment and Maintenance Activities Procedure | ||||
| Internal Audit Procedure | ||||
| Labelling Procedure | ||||
| Management Review Procedure | ||||
| Monitoring and Measurement & Data Analysis Procedure | ||||
| Nonconforming Product and Rework Procedure | ||||
| Performance Evaluation Procedure (IVD'S ONLY) | ||||
| Post Market Surveillance Procedure | ||||
| Preservation of Product Procedure | ||||
| Purchasing Procedure | ||||
| QMS Software Validation | ||||
| Quality Manual | ||||
| Regulatory Intelligence Procedure | ||||
| Risk Management Procedure | ||||
| Sales Order Processing Procedure | ||||
| Software Release and Deployment (When Relevant) | ||||
| Supplier Evaluation Procedure | ||||
| Technical File Procedure | ||||
| Unique Device Identifier (UDI) Procedure | ||||
| Usability Procedure | ||||
| Vigilance Reporting Procedure |
