Medical Devices Quality Consulting Service

Service Details:

With our experience, we are offering a vast collection of Quality Management Certification Services to our valued clients. These are widely used by the various organizations. Moreover, these certification services can be customized as per clients’ requirements. Further, offered services are available at the fair market price that fit each client's budget.

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• Higher competitive edge
• Rendered by our highly experienced staff
• Perfect work
• Flexible approach

Service Details:

The “Operon Strategist is working towards the catalyzing and ensuring the strategic development of the clients in the areas of Regulatory approvals , Quality Assurance, Quality Control, Licensing and Marketing authorization for the Medical Devices industry, Pharmaceuticals, R and D centers, CRO’s, Laboratories and Hospitals.

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Drug Master File Preparation Service is a mechanism that primary packaging manufacturers can use to share confidential information with health authorities without disclosing that information to the pharmaceutical industry. In the US, Drug Master File (DMF) is a submission to the US FDA that may be used to provide confidential detailed information about facilities, processes or articles used in the manufacturing, processing, packaging & storing of one or more human drugs. A DMF permits the sponsor to incorporate the information by reference when submitting an application.

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We are one of the trustworthy firms, involved in offering a wide gamut of ISO 13485 Consultancy Service to our clients. Offered array of services is rendered by our experienced professionals with following the industry quality norms. If regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system.

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• Use of sophisticated technology
• Executed by professionals
• Quick and prompt service

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Peron Strategist audits the existing CAPA Management system of clients & determines how effective it is in identifying & correcting quality problems.An effective corrective & preventive action system enable easy collection & analysis of information. This information is used identify & investigate existing & potential product & quality problems.

We also guide manufacturers in establishing an effective adverse event reporting system so that information regarding an adverse event/reportable event can be easily conveyed to regulatory bodies as well as the public.

After identifying a recurring quality problem, root cause analysis is done to identify the root cause of the recurrence. Once the root cause has been identified suitable corrective &/or preventive actions can be taken to avoid future recurrences

Service Details:

Operon Strategist is a consulting company for medical device industry,primary packing material manufacturing industry& pharmaceutical industry.(Medical device consultant, primary packing material consultant, pharmaceutical consultant) We help manufacturers of these industries to Design Layout as per all international & national guidelines to make your manufacturing unit compliantwith all regulatory requirements. synringe manufacturing consultant,orthopadic implant manufacturing consultant , Medical device disposable implant,Medical disposable syringe. 

Service Details:

After conceptualizing a new medical device, the next step in its product advancement is the design.This is the most important stage in the advancement of a medical device since a defective plan may prompt it being inadequate or dangerous (that is, not affirmed or cleared by the administrative organization).
At the design stage, an outline Control process should be started and actualized as a feature of the quality system requirement. Generally, outline controls are straightforward and logical steps to ensure that what you develop is what you meant to develop, and that the last item lives up to your client’s needs and desires.

Design and Development Planning: Build up and maintain a plan that describes the design and development activities and allocates the individual obligations for each activity. Guarantee you review, update and approve the plan until the device design is completed, verified and validated.

 

Design Input: Utilize performance, safety, business economics, outputs of risk management and regulatory requirements as a basis to plan the device with the goal that its motivation and the proposed utilize are clear. Input may also come from surveying your customers( For example , clinicians , nurses , patients).

Design Output: Design output methods or particulars need to stipulate or refer to the design input document developed by the team and need to identify the critical measures/outputs for the best possible capacity of the device. These incorporate the tests and strategies that may have been produced, adjusted or used to show conformance with the characterized configuration inputs. 

Design Validation: Approve the device design plan by means of examination and target prove, affirm that the last outline yield reliably meets the particular planned utilize. Design validation should follow successful design verification.

Design Changes: Guarantee that all plan changes are distinguished, documented, approved, verified, reviewed and endorsed before usage.


Design Transfer: Ensure that the design of the medical device can be correctly translated into production specifications (that is, advancing successfully from product development to manufacturing).

Design History File: The design history file (DHF) aggregates confirm (that is, the history of the design) that demonstrates that the outline was created as per outline controls???specifically , the design and development plan , or the outline change design.

 

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Clinical Evaluation of Medical Device is the assessment & analysis of clinical data pertaining to a medical device to verify its clinical safety & performance.Operon Strategist helps clients prepare a comprehensive clinical evaluation report by identifying the general safety & performance requirements that require support form relevant clinical data.We comb through various scientific databases such as PubMed , Cochrane etc. to search for available clinical data relevant to the device & its intended use.

Handling Customer Complaints: Medical device manufacturers ultimate user is the customer whose satisfaction in using a particular product is of utmost importance.Hence an efficient method of receiving & documenting customer complaints must be implemented. Moreover, detailed investigation must be carried out to determine the reason for the customer complaint & accordingly suitable corrective &/or preventive action must be implemented.

Service Details:

Validation is a process of establishing documentary evidence demonstrating that a procedure, process or activity carried out in production maintains the desired level of compliance at all stages. In particular, we provide the following validation services. Validation is an important cGMP requirement & many regulatory agencies audit the validation documentation. Since a wide variety of procedures, processes & activities need to be validated.

 

Operon Strategist guides manufacturers & validation service providers on the validation activity & documentation.We study the product & the production facility & accordingly design the validation master plan which outlines the validation activities to be performed & timeline for the same.We provide guidance for preparing validation protocols & reports in the correct format so as to meet the regulatory requirements including DQ, IQ, OQ & PQ protocols &; PQ report.

Service Details:

Having vast industrial experience and expertise, we have established ourselves as trustworthy service provider of Quality Control Consultancy. We have a team of experience professionals who survey the site before filling the tender and this help the client to decided weather they should go for it or not. Our rendered services are admired by our clients for their accuracy, reliability and many other features. Also, our offered services are easily affordable by our clients.

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Clean Room Design Consultant helps in Establishing & Maintaining an Environment with a low level of environmental pollutants such as dust, airborne microbes, aerosol particles & chemical vapors.

Clean Room Design consultant are offered on a one time fee basis or as several visits over time for a specific clean room project. With effective completion of over 50 Clean room projects, CAT conveys an unparalleled advisor experience level to your organization and to your personnel requiring particular guidance and proposals .Our team can give Auto CAD Clean room design services for most Clean room projects fo Manufacturing Industry, Building, Basic, Mechanical and Electrical controls.