• 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

latest PIC/S (Pharmaceutical Inspection Cooperation Scheme)

guidelines and GAMP (Good Automated Manufacturing Practice)

methods.

Our pharmaceutical documentation support includes many of the

services listed in the services section, including (but not limited

to) –

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 speci�cations

and quality attributes

are available."

Our regulatory expertise can help you:

• US Requirements:

• Pre-Market Notification — 510(k)

• Pre-Market Approval — PMA

• Combination Product (drug/device) Submissions

• Establishment Registration and Device Listing

• European Requirements

• Technical File, Design Dossier Preparation

• Clinical Evaluations

• CE Mark Facilitation

• SO 13485 Audits for Medical Device Companies

Medical device manufacturers must regularly conduct an audit of their ISO

13485 compliant quality management system. We can perform independent

quality system reviews for companies that are already ISO 13485 certified. We

can also help companies who are about to have their initial ISO 13485

certification audit by a notified body.

Pharmi Med Ltd. offer the following ISO 13485 auditor services:

ISO 13485 audits help to determine the actual status of your current quality

management system and processes. Pharmi Med Ltd offer the following ISO

13485 auditor services:

Off-site review of your current QA/RA documentation prior to your on-site ISO

13485 audit by a notified body. Review of your internal documentation to verify

that requirements have been addressed actual verification of ISO 13485 audit

requirements through review of objective evidence evaluation of current special

controls or validated processes; knowledgeable in various processes.

Additional ISO 13485 Audit Services

You can also contract us to conduct targeted ISO 13485 process audits in which

we focus on specific areas where noncompliance issues have occurred, or on

areas your internal auditors cannot audit due to conflicts of interest.

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

Pharmi Med Ltd have teamed up with Greenlight Guru, a

specialised electronic Quality Management System platform

which is specifically designed for medical devices. Pharmi

Med Ltd will work with your medical device company to get

you on the path to regulatory compliance in partnership

with Greenlight Guru, a web based system that is easy and

practical to use and will minimise your paper trail and

consequently your need for excessive consultant hours,

allowing you to focus on your product and getting it to

market. Greenlight Guru and Pharmi Med Ltd are both well

equipped with the specialised expertise and know-how to

get your device to market, and most importantly – STAY in

the market!

An entirely new way to manage your quality and compliance

The Greenlight Guru Story

The seeds for Greenlight Guru were planted back in 2006 by a

medical device engineer turned consultant as a result of a

simple observation; paper-based quality management systems

are painful, risky & wildly inefficient. Commercial quality

management software solutions have been available for over

20 years, yet only about 30% of medical device companies that

should be using them are. But why?

This observation and question led Jon Speer to team up with

David DeRam to create the vision for a beautifully simple

quality management software, which became the Greenlight

Guru platform. With our powerful, easy to use eQMS solution,

medical device companies can bring higher quality life

changing devices to market, faster – which, after all, is our

mission.

Design Control

At Pharmi Med Ltd we have invested our time to develop easy to use templates

for your business. This could save you thousands of pounds in consultancy fees

by utilising pre-populated templates for validation and compliance requirements.

All you have to do is simply pay and download your template and we will be

available for any online guidance in helping you populate your templates. Here

you will be able to preview part of the document, purchase and download a

complete editable Microsoft Word version.

Pharmi Med Ltd offers these tried and tested templates throughout the

Pharmaceutical and Medical Device Industry. We offer tailored services for

bespoke requirements such as validation for water, specific packaging

equipment, your facility, specific laboratory equipment, Standard Operating

Procedures, Risk Management and Design Control.

Please Contact Us With Your Exact Requirements

Downloadable Templates