+91 85869 76403
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+91 85869 76403
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1Sourcing of Raw Material and its Storage
We extract the best raw material, and sure that premium quality material is used for the final production. After import, the raw material is tested for quality. If it meets top quality standards, then it is stored in a sensitive condition in our storage spaces as per ISO standards of safety and hygiene. From the importing of raw materials to the development of products in-house, our state-of-the-art infrastructure enables us to operate efficiently. The final manufactured products are then forwarded for final check to our Quality Control Department. Thereafter, the products are neatly packed, accurately labelled, and stocked before distribution as per stipulated timelines. Shipping of products is done with utmost care and attention.
2Product Design
We have a team of researchers who come with decades of experience in designing implants. They help us meet the industry expectations while contributing in ideation and development of the products. With our research & development team, we are able to finalize theoretical blueprint, 3D models, and CAD/CAM.
3Prototyping
Next is the prototyping phase wherein we create the prototype of a specific design and conduct functionality tests upon it. If the prototype clears the tests, then we tick it off as fit for mass production. These prototypes are, however, subject to fatigue, static, torsion, and wear tests.
4Production Procedure
Our production process has been designed to customize products for our partners by fulfilling their specific requirements while keeping international quality control in mind. We also fine-tune the machines and systems to ensure that there is no room for any error. Besides this, we are thoroughly invested in our processes as we dedicate our time and resources to curate products that are complete value for money.
5Strength Testing
The Strength test methods are used to determine the fatigue life of the bone implant under a specific or over a range of maximum bending moment levels. ASTM F2068 lists four mechanical properties of orthopedic hip implants that must be tested prior to use in humans.
6Inspection
Orthopaedic implants typically require 100% inspection. This places great demands on the quality department’s resources. A single orthopaedic implant can comprise a variety of components and features demanding different inspection requirements. Non-prismatic features and complex geometries are typical in the orthopaedic implant world. Our world class Inspection Equipments have enabled us to inspect our Orthopaedic implants in the best possible way.
7Maintenance of Cleanliness
We have designed our rooms as per ISO 14644-1 under Category Class 10000 norms. These rooms are absolutely clean and offer an option to incorporate specific requirements that may help in assisting consumers’ needs.
8Best Packaging Practices
Equipped with excellent packaging facilities, we ensure that our packaging operations from sterile to non-sterile stages are conducted most efficiently. We make sure that our final products are packed in airtight boxes and labelled accurately as per the EN 980 standards.
Biotech’s Certifications
Our excellent product range has enabled us to receive essential accreditations, such as CE mark, ISO 9001:2015, ISO 13485:2016 and more. Biotech has received these certifications owing to our stringent focus on patients’ well-being. We even finalize our raw materials after a through vendor audit, nevertheless retaining reasonable prices on the materials.
