Medical Devices

1. • 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

2. Concept to Market
Development of a new product
Phase I
Initiation Opportunity and Risk
Analysis
Phase II
Formulation Concept and
Feasibility
Phase III
Design and Development /
Verification & Validation
Phase IV
Final Validation/ Product Launch
Preparation
Phase V
Product Launch and Post Launch
Assessment
Financial Review
Market Analysis
Competitive
Assessment
Early Risk
Assessment
Legal/IP Analysis
and Filings
Regulatory and
Clinical Path
R&D
Pharmi Med
Ltd
Operations.
Project
Core
Team
Project
Plan and
Timeline
Customer
Input/
Voice of
Customer
Customer
Prototype
Evaluation
Early
Concept/
Selection
Prototype
Analysis
Initiate and
Maintain
Design
History File
(DHF)
Initiate
Design Risk
Analysis
(dFMEA)
IP Landscape
Review & review
of Filing
Initial Regulatory
Strategy
Initial
Reimbursement
Strategy
Initiate DFM
(Tooling, Fixturing)
Customer
Prototype
Evaluation
Product
Design
Development
Design
Verification
and Validation
Maintain DHF
and Project
Timeline
Design Risk
Analysis
(dFMEA)
Patent Review
Regulatory
Strategy
Update
Regulatory
Submission
Begin IQ/OQ/
PQ Validation
Clinical
Validation
Plan
Product
Branding
Market
Launch
Plan/
Forecast
Marketing/
Sales
DHF
Completion
dFMEA
Update and
Review
Design
Outputs
&Inputs
Final Patent
Review with R&D
Obtain
Regulatory
Clearance
Finalise
Reimbursement
Strategy
Mfg/Ops Scale
Up
Full Process
Qualification
Final Process
IQ/OQ/PQ
Physician
Training
and Sales
efforts
Post Market
Surveillance
Update
Reimbursement
as needed
Process
Improvements
as needed
Update Design
Docs as
needed
Quality Audits
Other
Departments

3. 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

4. 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

5. 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

6. • 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 specifications
and quality attributes
are available."

7. 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.

8. 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

9. 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