Manufacturer and exporter of Orthopaedics, Oral-Maxillofacial & Plastic Surgery Implants & Instruments required for Trauma and Reconstructive surgery.

2. History
It was the year 1985 when the promoters started this journey by setting up a manufacturing unit in Mumbai for Orthopaedic Medical Devices.
Since then a number of mile stones have been added in the profile of this group. A separate sales organisation had been established in the year 1993
under the brand name of 'Ortho Care' and later on 'Ortho Max' reporting an unprecedented growth across industry.
It was a turn key decision when company decided to jump in the manufacturing & marketing of Cranio-Maxillofacial medical devices in the year 1994. We
have never looked back since then creating India's leading brand name in the field of Orthopaedics, Oral/Maxillofacial & Plastic Surgery.
We are in the 25 year of our venture and all set to add a new mile stone ahead.
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The Face & Vision
In October 2005 The Central Govt. of India issued a
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notification S. O. No.1468(E) dtd. 6 Oct - 2005 wide which all
the Medical Implants have been covered under Drugs &
Cosmetics Act 1940. Now these devices are to be
manufactured by only valid Drugs Mfg. License holders. We
have taken very early steps to fulfil the regulatory
requirements by setting up all new state of the art
manufacturing unit at Baroda in June 2007. The company
successfylly complied with the standards laid down by The
Indian FDAand got the manufacturing drugs licence in form-
28 on 26th June, 2009. We have also complied for "GMP"
Certification issued by The State FDA. The new unit has been
equipped with all modern manufacturing facilities. The
manufacturing activities are carried out under strict
supervision of technically competent persons. Our vision is to
offer quality products at affordable rates with unbeaten service
back up.
The Location
'Ortho Max' is located at most developed engineering industrial estate in Baroda. Baroda (Also known as Vadodara) is one of the fastest growing city and
engineering hub of Gujarat State, which is well connected with all road, rail and air ways. The city is well known for its cultural and royal heritage of King
Sir Sayaji Rao Gaekwad. The engineering industries of this city stand best in the country with all hi-tech facilities and available resources. Companies
like Reliance, FAG, L&T, Siemens, ABB, SUN Pharma, Alembic etc. have their presence in this city.
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3. The Infrastructure
The new unit is designed in a sprawling area to produce high quality medical devices
meeting all international parameters. The in-house lay out is perfectly designed with
sophisticated facilities to create efficient working environment :
• Each department is well equipped with all modern amenities.
• We have diversified all critical machine operations from conventional to all new
Computerised Numerical Control (CNC) Machines giving optimum desired quality &
uniformity.
• The unit has got best working conditions for all the employees with provision of all safety
& regulatory requirements. The unit is operated under Standard Operating Procedure
(SOP) giving highest efficiency in all department.
• All the operations are carried out under one roof for better traceability and control, right
from raw-materials lending to the finish product's dispatch.
R & D
All the research & development activities are conducted
indigenously by a team of experienced and skilled members The
AUTOCAD system is used for lay out inspection and approval. The
new products are developed under the guidance of senior
surgeons & technical consultants. A true to model accuracy is
designed and achieved with highest commitment & dedicated
team work of mechanical engineers & technicians.
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4. Machining
The whole machining process has been diversified to Computerised Numerical Control (CNC) achines of latest technology with high installed
capacity making our delivery schedule so prompt when you need in time. Each part is manufactured with high precision tools by skilled & experienced
machine operators & supervisors. The Special Purpose Machines (SPM) have been designed for all critical applications from 'Cutting to Finishing'.
m
The Raw Materials
The materials used in the manufacturing of medical devices require excellent chemical and
physical properties, high levels of purity and corrosion resistance. We always choose
selected materials which are highly bio-compatible for a medical applications. Our products
enjoy the fitness of international standards as per ISO 5832:1 for stainless steel and ISO
5832:3 for titanium implants. The materials are tested by a reputed laboratory for each and
every lot and the traceability is maintained throughout the manufacturing process.
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5. Line Inspection
The line inspection ensures that the desired quality parameters are maintained at each level of
manufacturing process. Each part is checked thouroughly before transferring to the next level of
machining. The system ensures that the non-conformance is verified at every stage and the right
product reaches to the next process.
Polish & Finish
We use special process for Grinding & Buffing. The Vibrator De-Burring Machines are installed for
edge free smooth surface of the devices by ceramics media. We have mastered the polish
treatment for elegant look and corrosion free service life of all the medical devices.
The Ultra-Cleaner
The cleaning system is equipped with 'Ultrasonic Cleaning Machine' with D.M. Water plant
for minimum in process contamination of other particles. All our products are made free
from dust & carbon particles for ready sterilisation to end user.
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6. Quality Control
In 'Ortho Max' the quality control system stands above all because we believe in self inspection as well as third party inspection for better surveillance
system and further improvement. Our whole Quality System right from planning of production to end sales of products is certified by ISO-9001:2008
Quality Management System and ISO 13485: 2003 Quality System especially for manufacturing of medical devices. Adding a new mile stone, our
products are now certified by CE (European Conformity) product certification. Each product is inspected thoroughly for all dimensions and working
fitness in state of art Quality Control Department by experienced members.
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7. Air Handling Unit (AHU)
The Quality Control and packaging area are designed as per the requirement of Schedule M-III
of Drugs & Cosmetics Act, 1940. The whole area is installed with 0.3 Micron Air Filters RAR
(Return Air Risers) and centrally air conditioning system for temperature control. This area
offers most hygienic and safest climate conditions for final processing and packaging of the
medical devices.
Marking
All our devices are laser marked for size & brand name with a latest 'Fibre-Pulsed Laser Mark
Machine' specially designed for Stainless Steel and Titanium Medical Devices. This fibre
pulsed laser technology gives smooth and permanent precise marking without cutting the
surface which is essential for Medical Devices. We ensure full traceability of our products.
Packaging
The packaging of finally inspected products is
carried out in a highly clean room with 0.3
Micron Contamination Air Flow. This is to give
you cleanest and safest devices ready for
sterilisation process. The label graph is also
designed as per 'CE' product certification
requirement to give you total information
about device and manufacturer.
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8. Certifications
1. The Company has established a sound quality control system by implementing Quality Management System of ISO 9001:2008 at all levels of
production & sales. Apart from the management system the company has also implemented quality standards throughout the manufacturing
process and this system is certified for ISO 13485:2003 especially applied to manufacturing of medical device.
2. Above all Quality Management System we have touched the highest parameter of product quality by having the ' ' product certification from a
reputed European Notifying Body ITC 1023 which explores the overseas market for our products.
3. The Company has got the valid Drugs Manufacturing License from the Ministry of Health & Family Welfare, Govt. of India. This is a regulatory
requirement for manufacturing medical devices in India now.
4. The entire manufacturing system has been certified for Good Manufacturing Practices " G.M.P. " certification from the State FDA.
CE
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9. Customer Care
info@orthomaxindia.com, orthomax@vsnl.net
'Ortho Max' has established a sound customer care system by taking 'Customer Feedback Form' frequently which is a mandatory
requirement of ISO 9001 : 2008 Quality Management System. The same are reviewed and discussed in every management review
meeting.
We care for each and every enquiry or complaint we receive and the same gets sorted out in time. Our fast sales and delivery services
are considered among the best in the country. We listen and act carefully for every suggestion received from our valued customers. The
success story of our organisation is based on 'Better Customer Relationship' over the period of time. The customer satisfaction index
level shows continual improvement.
Our valued customers can post their feedback any time at
OR
the same can be conveyed by a phone call to our customer care phone number. We assure you to respond within 48 hours. Dealers are
also available in different territories to provide round the clock services.
Pradeep Trivedi
+91 94276 03431
C.E.O.
Kaushik Hingrajiya
+91 94283 01731
Gen. Manager
Niraj Gohel
+91 94273 81644
Area Manager (North)
Jatin Patel
+91 98253 98308
Regi. Head (Gujarat)
Customer Care No.
+91 265 2425658
Office Hours : 10.00 a.m.To 7.30 p.m. (Except Sunday)
Always at your services :
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10. Sales Network
The sales network of 'Ortho Max' has
touched almost all the corners of India and
South Asian countries having one of the
largest customer network in Orthopaedics-
Oral/Maxillofacial & Plastic Surgery. Our new
expansion covers Africa-Middle East and
some of the European countries.
Authorised Distributors & Dealers are
appointed in almost all the Metro and Sub-
Metro level cities for your round the clock
services. We are a regular participant of all
the annual conferences, seminars ,
workshops and trade exhibitions.
You will not feel untouched
wherever you are.
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BARODA
ALLAHABAD
VARANASI
PATNA
GAYA
AMRITSAR
JALANDHER
LUDHIANA
SHIMLA
ROHTAK
CHANDIGARH
NEPAL
LUCKNOW
DELHI
MEERUT
GORAKHPUR
JAIPUR
GWALIOR
BHOPAL
INDORE
AHMEDABAD
SURAT
NAGPUR
MUMBAI
PUNE
HYDERABAD
VISHAKHAPATNAM
VIJAYAWADA
GUNTUR
CHENNAIBANGALORE
KOZHIKODE
KOCHI
THRISSUR
SRILANKA
KOTTYAM
COIMBATORE
MADURAI
RAIPUR
BHUBANESHWAR
KOLKATA
BANGLADESH
GUWAHATI
DIBRUGARH

11. Right from production to sales we deserve the satisfaction of hundreds of our valued customers and employees without which we would not have come
to the destination we have reached today…….
The Team
The team behind the success of the company has a healthy presence of more than 100 members whose dedication and commitment have laid down a
strong foundation of this company. Each member of this team is full of energy, enthusiasm, sincerity and confident to give his or her best at all. The top
management provides all the motivations and resources to achieve the desired objectives.
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12. QUALITY POLICY
" QUALITY "
THE ENTIRE GOUP OF Ortho Max IS COMMITTED TO PROVIDE BEST QUALITY PRODUCT
IN TIME AT AFFORDABLE RATES WITH MODERN TECHNOLOGICAL SOLUTION OF TODAY'S
MEDICAL FIELD.
EACH MEMBER OF THIS GROUP IS ADHERED TO ACHIEVE THE DESIRED OBJECTIVE AND
GOALS BY EVERY MEAN.
WE APPRECIATE AND WELCOME YOUR VALUABLE SUGGESTIONS FOR CONTINUAL
IMPROVEMENT. KINDLY POST YOUR FEEDBACK AT
AND JOIN US IN THE ENDLESS JOURNEY CALLED
info@orthomaxindia.com or orthomax@vsnl.net
www.orthomaxindia.net
ALL THE DOCUMENTS OF QUALITY SERIES WILL BECOME A MERE PIECE OF PAPER IF
NOT CULTIVATED BY A PERSONAL COMMITMENT AT EVERY STAGE. WE AT Ortho Max
BELIEVE IN MAINTAINING HIGH QUALITY STANDARDS RIGHT FROM PROCURING RAW
MATERIALS TO END SALES BACKED BY SUPERIOR POST SALES SERVICES.