Documentation
Crucial to all regulatory submissions is the planning, completion,
review, approval and collation of Technical Documentation to
evidence the safety and performance of the device(s). We have the
expertise in the definition, planning / collation of documentation
and possess excellent, efficient templates and documentation
formats, that guide our Clients and simplifies the completion of
data for submission to the regulatory authorities. Examples of such
document and data requirements include:
- EC Harmonised Standards, US Performance Standards, ISO
Standards and National Standards.
- Medical Device Regulations for various countries
- Quality Management System Standards
- Hazard Identification, Analyses & Risk Management
- Essential Requirements Checklist.
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EC / ISO / US / National
Standards |
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Identifying and providing support to ensure compliance with EC
Harmonised Standards and ISO Standards for Medical Device
design, including software design, risk management, manufacture,
packaging, sterilisation, labelling and post market
surveillance.
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Regulatory |
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Defining and ensuring
documentary evidence of compliance with all
the EC
Directives.
Establishing material and product
specifications.
Assessing / Testing for material biocompatibility.
Collating documents to meet EC
Technical Files, Design Dossiers, Canadian
Medical Device Compliance Assessment System, (CMDCAS),
Design History Files and Device Master Records
as specified in FDA 21 CFR 820 US Regulation.
Conducting tests on materials, product and
packaging to meet clinical, market and
regulatory acceptance.
Preparing regulatory submissions to the
National Authorities including Notified Bodies
/ Registrars and the FDA.
Preparing and assisting our Clients in
assessments and inspections.
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QA / RA Documentation |
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Hands on
support to design and implement effective management
systems to meet standards and regulation such
as ISO13485, CFR820 and CMDCAS.
Conducting FMEA's and risk assessments to meet
ISO 14971.
Completing Design & Process Validations.
Assisting in preparation, of documentation and
maintaining systems to meet required standards
/ regulation.
Delivering audit services including the
assessment of suppliers and distributors.
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