• Validation • Quality Management System & CE Marking • Regulatory Services • Auditing Services • Risk Management • Design Control • Audit Remediation • Our Medical Device support services cover Class I, II and III Pharmi Med Ltd is a consultancy firm which believes in long term partnership. We support short term, medium term and long term project work for small-medium sized businesses, as well as large corporations which may have a shortage in a skill or wish to outsource work to improve productivity. We help companies establish quality management systems (QMS) which are compliant with medical device industry standards. We also provide guidance where regulatory requirements can be overwhelming and confusing. Pharmi Med Ltd is a one stop solution for ensuring that your company’s medical devices are firmly on track for being approved for sale in target markets. The following are some of the services we can provide to your company: Who We Are / Services
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• Validation
• Quality Management System & CE Marking
• Regulatory Services
• Auditing Services
• Risk Management
• Design Control
• Audit Remediation
• Our Medical Device support services cover Class I, II and III
Pharmi Med Ltd is a consultancy �rm which believes in long term
partnership. We support short term, medium term and long term
project work for small-medium sized businesses, as well as large
corporations which may have a shortage in a skill or wish to
outsource work to improve productivity.
We help companies establish quality management systems (QMS)
which are compliant with medical device industry standards. We
also provide guidance where regulatory requirements can be
overwhelming and confusing. Pharmi Med Ltd is a one stop solution
for ensuring that your company’s medical devices are �rmly on
track for being approved for sale in target markets. The following
are some of the services we can provide to your company:
Who We Are / Services
Concept to Market
Development of a new product
Phase IInitiation Opportunity and Risk
Analysis
Phase IIFormulation Concept and
Feasibility
Phase IIIDesign and Development /
Verification & Validation
Phase IVFinal Validation/ Product Launch
Preparation
Phase VProduct Launch and Post Launch
Assessment
Financial Review
Market Analysis
CompetitiveAssessment
Early RiskAssessment
Legal/IP Analysisand Filings
Regulatory andClinical Path
R&D Pharmi MedLtd Operations.
ProjectCoreTeam
ProjectPlan andTimeline
CustomerInput/
Voice ofCustomer
CustomerPrototypeEvaluation
EarlyConcept/Selection
PrototypeAnalysis
Initiate andMaintainDesign
History File(DHF)
InitiateDesign Risk
Analysis(dFMEA)
IP LandscapeReview & review
of Filing
Initial RegulatoryStrategy
InitialReimbursement
Strategy
Initiate DFM(Tooling, Fixturing)
CustomerPrototypeEvaluation
ProductDesign
Development
DesignVerification
and Validation
Maintain DHFand Project
Timeline
Design RiskAnalysis(dFMEA)
Patent Review
RegulatoryStrategyUpdate
RegulatorySubmission
Begin IQ/OQ/PQ Validation
ClinicalValidation
Plan
ProductBranding
MarketLaunchPlan/
Forecast
Marketing/Sales
DHFCompletion
dFMEAUpdate and
Review
DesignOutputs&Inputs
Final PatentReview with R&D
ObtainRegulatoryClearance
FinaliseReimbursement
Strategy
Mfg/Ops ScaleUp
Full ProcessQualification
Final ProcessIQ/OQ/PQ
PhysicianTraining
and Salesefforts
Post MarketSurveillance
UpdateReimbursement
as needed
ProcessImprovements
as needed
Update DesignDocs asneeded
Quality Audits
OtherDepartments
Design and Development
Industry Requirements & Validation
After conceptualising a new medical device, the next step in product
development is the design. This is the most important stage in the
development of a medical device since a flawed design may lead to
it being ineffective or unsafe. At the design stage, a design control
process needs to be initiated and implemented as part of the quality
system requirement.
At Pharmi Med Ltd we can complete documentation from start to
finish or support to meet requirements for FDA 21 CFR part 820.30,
and ISO 13485 clause 7.3:
• DESIGN AND DEVELOPMENT PLANNING
• DESIGN INPUT
• DESIGN OUTPUT
• DESIGN REVIEW
• DEVICE MASTER RECORD (DMR)
• DESIGN HISTORY FILE (DHF)
• TECHNICAL FILE (TF)
• DESIGN CHANGES
• DESIGN TRANSFER
• DESIGN VALIDATION
• DESIGN VERIFICATION
Pharmi Med Ltd can
assist in the compilation and
organisation of your DHF/DMR
or Technical File. We can support in
these activities for new products,
remediation for FDA clearance or
CE Marking. We will simplify the
entire submission process
Pharmi Med Limited will help you remain compliant with the
regulations. In the context of the Pharmaceutical and Medical
Device industries, validation is a process that businesses must
invoke throughout their company to ensure meeting the regulatory
requirements prior to market launch. It is the manufacturer’s
responsibility to ensure that there is adequate validation of all
processes involved in the production of any of these products. We
cater for equipment, cleaning and process validation.
Validating a process from beginning to end is a daunting task which
can involve an entire trail of quality assurance, not only of the
equipment involved in the production of your product, but also storage
conditions. Process Validation should verify that procedures and
processes, used in the manufacturing of your product, are suitable for
their purposes and guarantee that the process used will consistently
meet its predetermined specifications and quality characteristics. The
procedure must outline the way of carrying out an activity. The process
is a set of methods and actions which interact to convert what goes in
to what comes out.
In the context of the
Pharmaceutical and Medical Device
industries, validation is a process that
businesses must invoke throughout their
company to ensure meeting the
regulatory requirements prior
to market launch.
Validation
Pharmi Med Ltd is a one stop solution for medical devices
which covers guidance for European requirements for CE
marking using Medical Device Directive 93/42 EEC, In Vitro
Medial Device Directive 98/79 EC, FDA requirements for
United States, as well as ROW (Rest of World). Our concept to
market graphic explains the stages where we will help you.
Our support includes knowledge of the appropriate standards
and several product specific standards.
Our Medical Device support services cover Class I, II and III
Medical Device Documentation Support
Pharmi Med
can help from set up,
to assistance with new
product development, to
ongoing validation and
regulatory, and remediation
work from audits. We can
also help you with a
Gap Analysis
• SOP Write Up
• Setting up Quality Management Systems or
Review of Quality Documentation
• Validation
• Laboratory Setup
• Cleanroom Setup
• Facility Setup/New or Modified Production Lines.
We can support combination devices which include the
requirements of both medical devices and pharmaceutical
regulations, as well as herbal/supplementary products which
may require GMP.
Pharmi Med Ltd has supported many pharmaceutical companies,
including start-up businesses, to meet cGMP (current good
manufacturing practises), Eudralex Annex 15 and MHRA
requirements, including FDA part 210 and 211. We also use the