Operon Strategist
Operon Strategist
Pimpri Colony, Pimpri Chinchwad, Maharashtra
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Medical Devices Quality Consulting Service

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

US 21 CFR 820.30 Design Control Requirements

US 21 CFR 820.30 Design Control Requirements
  • US 21 CFR 820.30 Design Control Requirements
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Approx. Price: Rs 2 / SetGet Latest Price

Service Details:

Minimum Order Quantity1 Set
Type of IndustryManufacturing

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. Examples of design outputs may include:

  • The device itself.
  • The user manual.
  • Specifications A Risk AnalysisStudy results (For examples, validation and biocompatibility studies, storage ).
  • Technical Files.

 

Design Review:

Confirm the design, or identify at an opportune time and right any in sufficiencies distinguished at other plan and improvement phases. Two common types of review are hazard analysis, and failure mode and effect analysis.

Design verification:

confirm the device outline by means of examination and target prove, verify that the design outputs meet the plan inputs. Design verification activities must be arranged and routinely analyzed and the outcomes must be documented.

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.
Since outline check is directed while the plan work is being performed, design validation confirms that the medical device meets its intended use.Generally, this is set up through in vitro execution, practical testing, creature testing and additionally in vivo clinical assessments and trials.

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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Drug Master File Preparation Service

Drug Master File Preparation Service
  • Drug Master File Preparation Service
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Service Details:

Minimum Order Quantity1 Set
Preferred LocationIndia
Type of Industry / BusinessMedical Device, Pharmaceutical, Chemical Industries, Plastic Industries
Project Duration2 Months
Type of Industry / BusinessMedical Device, Pharmaceutical, Chemical Industries, Plastic Industries
Project Duration2 Months

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.

 

Currently, the different types of DMF include:

  1. Type II Drug substance, drug substance intermediate & material used in their preparation or drug product
  2. Type III Packaging material
  3. Type IV Excipient, colorant, flavor, essence or material used in their preparation
  4. Type V FDA accepted reference information
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Quality Consulting Service

Quality Consulting Service
  • Quality Consulting Service
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Service Details:

Type of Service ProviderConsulting Firm
Type of CertificationNew Certification
Type of IndustryChemical

Having vast industrial experience and expertise, we have established ourselves as trustworthy service provider of Quality Control ConsultancyWe 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.

NOTE :- Price Can Be Change According To Project Size
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Clinical Evaluation of medical Device

Clinical Evaluation of medical Device
  • Clinical Evaluation of medical Device
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Service Details:

Minimum Order Quantity1 Unit
TypeDigital, Manual, Portable
Application Radiology, Gynecology, Audiology, Neurology, Cardiology

Clinical evaluation 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.

We Provide Medical Device Post Market Support includes Following stages:
Ongoing system and maintain the compliances during ongoing commercial manufacturing process.
CAPA compliance.
Audit Report & Compliance.
Labeling Compliance.
Clinical Evaluation & Post Marketing Survillance.
Medical Device Reporting.
Customer Complaints.We can handle such incidences very effectively and efficiently.
Design Output, Design verification & Design Validation.

Medical device vigilance & medical device reporting are two of most commonly used methods for reporting adverse events in the EU & US respectively. Other sources for gathering information includes product or customer surveys, literature review, service reports, regulatory filings, etc.

Related Projects:

 

Name: Handling Customer Complaint
Year: 2001
Type: Got it

 

Name: Audit Report & Compliance
Year: 2003
Type: Got it

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Quality Management Consultancy

Quality Management Consultancy
  • Quality Management Consultancy
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Service Details:

Type of CertificationNew Certification
Type of IndustryChemical
Type of Service ProviderConsulting Firm

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.

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


Operon Strategist is a registrar / certification body for quality management certification. We are leading service provider for quality management system
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Quality Accreditions Service

Quality Accreditions Service
  • Quality Accreditions Service
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Service Details:

Type of CertificationNew Certification
Type of IndustryManufacturing
Type of Service ProviderConsulting Firm

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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ISO 13485 Consultancy Service

ISO 13485 Consultancy Service
  • ISO 13485 Consultancy Service
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Service Details:

Type of Service ProviderConsulting Firm
Type of CertificationNew Certification
Preferred LocationIndia

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.

Other Details:
  • Use of sophisticated technology
  • Executed by professionals
  • Quick and prompt service
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CAPA Management

CAPA Management
  • CAPA Management
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Service Details:

Minimum Order Quantity1 Set
Type of Service ContractRetainer Based
Type of IndustryManufacturing
Type of Service ProviderConsulting Firm

peron Strategist audits the existing CAPA 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.

Operon Strategist helps manufacturers design a PMS plan specific to a product or family of products.

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

Related Projects:

 

Name: Handling Customer Complaint
Year: 2001
Type: Got it

 

Name: Audit Report & Compliance
Year: 2003
Type: Got it

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Equipment & Utilities Validation

Equipment & Utilities Validation
  • Equipment & Utilities Validation
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Service Details:

Minimum Order Quantity1 Unit
Type of Service ProviderConsulting Firm

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.

Manufacturing Plant Setup Design Consulting Services For Orthopedic implant Manufacturing Industry, surgical instrument manufacturing, dental instrument manufacturing Industry,implant-manufacturing, implantable-molding, instrument-manufacturing, endodontic-instrument, diagnostic-instrument manufacturing Industry, equipment manufacturing, sterilizers manufacturing, syringe manufacturing, Disposable Plastic Syringes.

We Provide Manufacturing Site Conceptualization project services includes Following :

Equipment & Utilities validation
1. Facilities,Utilities & Equipment Validation For Medical Device:

Equipment Validation Essential element in the Establishment and implementation of a process procedure as well as in determining what process controls are required to assure medical device specifications.-Validation is an essential control for assuring that the specifications for the device and manufacturing process are adequate to generate a device that will conform to the approved design characteristics.

2.Equipment & Utilities Validation For Primary Packaging.
Operon Strategist is an primary packaging consultant for Facility ,Equipment and utility system qualification and validation projects for pharmaceutical , Medical device companies including related process validation.

Equipment Selection & Sourcing
Equipment Selection & Sourcing is Key Parameter for Manufacturing unit &utilize them to Meet national & International level.Write Equipment Selection & Sourcing Saves The Time & Helps in Better usability of Equipment.

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Clean Room Design Consultant

Clean Room Design Consultant
  • Clean Room Design Consultant
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Service Details:

Minimum Order Quantity1 Unit
Type of Service Provider Consulting Firm

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

Presence of unwanted air particles may adversely affect the performance and safety of a product and hence Medical Device manufacturers are advised to manufacture under classified areas.Clean rooms of different sizes and complexity are designed to maintain low levels of air particles as per the as per the ISO 14644 clean room standards.

As a Medical Device clean room design consultant, Operon Strategist helps in the design of Medical Device clean room as per the desired levels of air quality. In addition, to controlling the air particle count, environmental factors such as humidity, temperature, and pressure are also considered while designing a clean room.

Clean room consultant services 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 for Manufacturing industry , building, basic, mechanical and electrical controls.

We as clean room design consultant , guide Medical Device manufacturerson supporting elements to maintain the clean room conditions suitable for manufacturing like Entry exit procedures, Gowning procedures etc

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Medical Device Process Validation

Medical Device Process Validation
  • Medical Device Process Validation
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Service Details:

Minimum Order Quantity1 Unit
Type of Industry / BusinessMedical Device Industries

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.

Medical Devices Validation services
Validation is an important cGMP requirement & many regulatory agencies audit the validation documentation. Validation of a machine or a process is carried out to ensure that products of consistent quality are manufactured and required level of compliance is met at every stage. Since a wide variety of procedures, processes & activities need to be validated; validation is divided into the following sub-sections:
• HVAC validation
• Equipment validation
• Process validation
• Facilities validation
• Cleaning validation
• Analytical method validation
• Personnel validation
• Packaging validation
• Computer system validation
Being a medical device consultant, Operon Strategist guides manufacturers & validation service providers for the validation activity & documentation. The product and the production facility are studied to document the validation master plan according to which validation activities will be performed as per the defined timeline

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Anil Chaudhari (Proprietor)
MSR Capital, Office No. 10, 3rd Floor, Old Mumbai Pune Highway Morwadi, Pimpri Colony
Pimpri Chinchwad- 411018, Maharashtra, India



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