Medical device packaging importance

 

Medical device packaging importance states the packaging of medical devices frequently takes place in a clean room, and the packaged devices normally undergo some kind of sterilization. But it is the role of packaging to keep the device sterile right up until use. The correct selection of packaging, therefore, is a crucial but complex decision, and statistics suggest it is often not carried out correctly. 

Medical device packaging importance is a crucial part of the industry with its own separate set of safety and security concerns, for good reason. Packaging serves a number of purposes. It not only protects a product from harm or tampering during transit but can display critical product information and brand marketing. 

• Operon Strategist provides worldwide packaging consultants services to the primary packaging and pharma industries, including strategic, regulatory and environmental compliance.   

Medical device packaging importance is in a class all of its own, due to the important equipment it carries. This makes safety and security measures top priority for this type of packaging. 10% of medical device recalls are attributable to packaging failures and 31% of those are due to a hole in the packaging.

Medical Packaging Standards 

An overview of the current status of the relevant medical packaging standards ISO 11607-1 is the most important. It states that medical device packaging should be:

• Made of known and traceable materials
• Non-toxic, non-leaching and odorless
• Free of holes, cracks, tears, creases and localized thinning
• Intended for use in medical applications.

It must also:

• Allow sterilization
• Provide physical protection
• Maintain sterility up to the point of use
• Allow aseptic presentation.

The packaging is a highly significant part of the medical device market with its own separate set of security and concerns for safety reasons of the consumers. The packaging carries out a number of purposes, not only it protects the product from contamination or harm, but also displays crucial products information and does brand marketing.

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1. Orthopedic Implants Manufacturing

2. disposable syringe manufacturers

3. Dental Implants Manufacturing

4.Blood Collection Tubes Manufacturing

Contact details –

Phone  no -  93702 83428

Mail id – enquiry@operonstrategist.com

If  You Want Medical Devices Services Consultation For Following.

1. Medical Device Consulting 
2. cdsco registration 
3. FDA 510k Clearance 
4. ce mark medical device 
5. CDSCO Manufacturing License 
6. CDSCO import license 
7. TURNKEY PROJECT CONSULTANT 
8. medical device manufacturing 
9. iso 15378 certification 
10. 21 cfr part 210 and 211 
11. ISO 13485 Medical Device Consultant 
12. Primary Packaging Turnkey Project Consultant 
13. Clean Room Design Consultant 
14. manufacturing site conceptualization 
15. Market Analysis and feasibility for Medical Devices 
16. manufacturing plant layout design 
17. medical device design and development 
18. DMF file submission guideline 
19. 21 cfr part 820 
20. qms certification services 
21. capa management 
22. design control requirements 
23. medical device process validation 
24. combination product 
25. continuous improvement program 
26. Medical Device Compliance & Regulatory Services 
27. Cdsco India authorized agent for medical device   

Benefits of FDA 21 CFR Part 11

 

Benefits of FDA 21 CFR Part 11 provide an opportunity for medical device companies to reap the organizational advantages of paperless record-keeping systems. It also helps the FDA ensure that when medical device companies use electronic record-keeping systems, that document security and authenticity are adequately maintained.

The regulation sets out a framework for properly managing digital records so that they meet the requirements for regulatory inspection by the FDA. While facilitating regulatory oversight is the core focus by Benefits of FDA 21 CFR Part 11, the driving force behind it was, in fact, to ease the cost and burden of maintaining paper records to satisfy regulators.

• Operon Strategist is FDA 510 k process consultant helps the clients to register SBU (Small Business Unit), if applicable. 

• Take out the testing requirement of the product, creation of the dossier, resolving the queries and after completion of all the activities.

Benefits of FDA 21 CFR Part 11 validation can be challenging depending on the type of quality management system you’re using, but it shouldn’t deter you from using a software of any sort to manage these functions.

Benefits of FDA 21 CFR Part 11 establishes the standard criteria under which the FDA considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper

It is meant to ensure the authenticity, integrity, and confidentiality of electronic records. These rules and regulations help to ensure robust and reliable study data that will stand up to the scrutiny of regulation and help to ensure future patient safety and effective medicines. Most companies have focused their Benefits of FDA 21 CFR Part 11 compliance efforts on manufacturing, on clinical trials, and on development, because that has been the focus of FDA auditing efforts. But it also makes good sense to design a discovery automation system to comply with Part 11.

What is US FDA 21 CFR Part 11?

FDA 21 CFR Part 11 allows medical device and life science organizations to use electronic records and signatures in place of paper.
The regulation applies to all aspects of the research, clinical study, maintenance, manufacturing, and distribution of medical products, and covers:

• Required records that are maintained in electronic format in place of paper format
• Required records that are maintained in electronic format in addition to paper format, and that are relied on to perform regulated activities
• Records submitted to FDA in electronic format
• Electronic signatures that are intended to be the equivalent of handwritten signatures.

Read More - Benefits of FDA 21 CFR Part 11 

Read More Article - 

1. Orthopedic Implants Manufacturing

2. disposable syringe manufacturers

3. Dental Implants Manufacturing

4.Blood Collection Tubes Manufacturing

Contact details –

Phone  no -  93702 83428

Mail id – enquiry@operonstrategist.com

If  You Want Medical Devices Services Consultation For Following.

1. Medical Device Consulting 
2. cdsco registration 
3. FDA 510k Clearance 
4. ce mark medical device 
5. CDSCO Manufacturing License 
6. CDSCO import license 
7. TURNKEY PROJECT CONSULTANT 
8. medical device manufacturing 
9. iso 15378 certification 
10. 21 cfr part 210 and 211 
11. ISO 13485 Medical Device Consultant 
12. Primary Packaging Turnkey Project Consultant 
13. Clean Room Design Consultant 
14. manufacturing site conceptualization 
15. Market Analysis and feasibility for Medical Devices 
16. manufacturing plant layout design 
17. medical device design and development 
18. DMF file submission guideline 
19. 21 cfr part 820 
20. qms certification services 
21. capa management 
22. design control requirements 
23. medical device process validation 
24. combination product 
25. continuous improvement program 
26. Medical Device Compliance & Regulatory Services 
27. Cdsco India authorized agent for medical device