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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
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 RiskAnalysis(dFMEA)
IP LandscapeReview & review
of Filing
Initial RegulatoryStrategy
InitialReimbursement
Strategy
Initiate DFM(Tooling, Fixturing)
CustomerPrototypeEvaluation
ProductDesign
Development
DesignVerificationand Validation
Maintain DHFand ProjectTimeline
Design RiskAnalysis(dFMEA)
Patent Review
RegulatoryStrategyUpdate
RegulatorySubmission
Begin IQ/OQ/PQ Validation
ClinicalValidationPlan
ProductBranding
MarketLaunchPlan/
Forecast
Marketing/Sales
DHFCompletion
dFMEAUpdate andReview
DesignOutputs&Inputs
Final PatentReview with R&D
ObtainRegulatoryClearance
FinaliseReimbursement
Strategy
Mfg/Ops ScaleUp
Full ProcessQualification
Final ProcessIQ/OQ/PQ
PhysicianTrainingand Salesefforts
Post MarketSurveillance
UpdateReimbursementas needed
ProcessImprovementsas needed
Update DesignDocs asneeded
Quality Audits
OtherDepartments
Design and Development
Industry Requirements & Validation
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
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
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
Pharmaceutical Documentation Support
Pharmi-Med Ltd will
achieve GMP requirements of
"establishing documented evidence
that establishes a high degree of
certainty that a particular process
will consistently produce a product
that provides the previously
established specifications
and quality attributes
are available."
Our regulatory expertise can help you:
Pharmi Med Ltd. offer the following ISO 13485 auditor services:
Additional ISO 13485 Audit Services
We can also implement ISO 9001 Quality Management Systems. Please contact us for more information on our ISO 13485 and ISO 9001 auditing service
We can do an off-site review of your current QA/RA documentation prior to your on-site
ISO 13485 audit
Auditing and Regulatory Services
Regulatory requirements for medical devices can be very daunting without the correct knowledge and experience. Understanding regulatory requirements for each geographical agency can have its own challenges and lengthy processes.
Greenlight Guru – The Software
An entirely new way to manage your quality and compliance
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Design Control
Please Contact Us With Your Exact Requirements
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