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.

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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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