Design and development of Combination Products

Design and development of Combination Products

Combination Products (e.g. Drug, device combination products like prefilled syringes, applicators of the tropical products) manufactures shall have adequate design and development activity done so as to prove the adequacy of the safety and efficacy of the product.The design and development activity is the systematic methodology, which establishes the proper design and development of the products.

Many of the customer complaints and 483’s in case of the medical devices or combination devices are contributed to the improper of the design and development control activity.The design and development requirements of the product are described in ISO 13485: 2016 and 21 CFR Part 820 also.

Combination Products Project Development Process & Design Control

The Pharmaceutical organization which manufacturers the combination products are expected to implement the 21 CFR Part 210 and 211 and 21 CFR Part 820 for their manufacturing sites of the combination products. At the end of the design Phases, the DHF is compiled and shall be presented during the audits.

• The DMR shall be extracted from the DHF for the routine use and the tech transfer.
• The requirements mentioned in the DMR shall be used to create the DHR to demonstrate the routine production and compliances.
• As per the requirements of the ISO 13485:2016, the medical device file shall be established.
• The complexity of the design procedure is dependent on the Product complexity and intended use.
• The design control is a vital part as far as the Quality Management System( QMS certification)  goes.
• Operon Strategist assists companies and medical device manufacturers by providing consultancy services that support the registration of drug-device Combination Products.

We have experience with each constituent part and the GMP regulations that together form the basis for their development and manufacture: Drug  (21 CFR 210/211), Device (21 CFR 820) and 21 CFR Combination Products (21 CFR Part 4)

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Contact details –

Phone no -  9325283428

Mail  - dm@operonstrategist.com

If  You Want Medical Devices Services Consultation For Following.

    1.     Medical Device Manufacturing

    2.     CDSCO Registration

    3.     FDA 510 k clearance

    4.     Continuous Improvement Program

    5.     Design Control Requirements

    6.     QMS Certification Services

    7.     Manufacturing Plant Layout Design

    8.     Primary Packaging Consultant

    9.    CE Marking Consultant 

 10. Combination Product

 11. Medical Device Design And Development 

 12. Clean Room Design Consultant

 13. ISO 13485 Certification

 14. ISO 15378 certification

 15. Medical Device Process Validation

 16. 21 cfr part 820

 17. 21 cfr part 210 and 211

 18. DMF submission

 19. CAPA Management

 20. TURNKEY PROJECT CONSULTANT

 21. Manufacturing Site Conceptualization