QSR 21CFR Part 820 Implementation Assistance:

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The Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments.

FDA’s Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, re-label, and/or import medical devices sold in the United States.

Any device that reaches US market via a 510(k) notification must be “substantially equivalent” to a device legally marketed in United States.The legally marketed device(s) to which equivalence is drawn is commonly known as the “predicate device”. If a device being submitted is significantly different, in terms of design, material, chemical composition, energy source, manufacturing process, or intended use, the device nominally must go through a premarket approval, or PMA. This does not always happen.

We are consultants assisting organization to comply with 21 CFR Part 820 (US FDA GMP for Medical Device manufactures) of US federal law and complete 510(k) applications successfully and fast.

ISO 13485:2003/EN ISO 13485:2012 Implementation Assistance

Medical Device manufactures, Medical Device designers and pharmaceutical suppliers are interested to prove there devices are manufactured under certain Global Harmonized standards . ISO 13485:2003/ EN ISO 13485:2012 Certification is a solution for this concern!!!

Regulatory authorities in most major markets like European Union, United States, Australia, Canada, Japan, Taiwan, Singapore & Korea require, or strongly desire, that manufacturers marketing medical devices in their countries have a third-party audited and certified Medical Device Quality Management System in place. An ISO 13485:2003 /EN ISO 13485:2012 compliant system expedites access into those countries that require it.

EN ISO 13485:2012 Certificate will be issued by an accredited third-party after assesses your compliance towards Medical Device Quality Management System.

We are here to assist you to implement the system as per the requirements.

Assistance for 510K submission/ Pre Market approval(PMA)

  • Medical devices are classified into Class I, II, and III.
  • Regulatory control increases from Class I to Class III.
  • FDA classifies medical devices based on the risks associated with the device. Devices are classified into one of three categories—Class I, Class II, and Class III.
  • Class I devices are deemed to be low risk and are therefore subject to the least regulatory controls. For example, dental floss is classified as Class I device.
  • Class II devices are higher risk devices than Class I and require greater regulatory controls to provide reasonable assurance of the device’s safety and effectiveness. For example, condoms are classified as Class II devices.
  • Class III devices are generally the highest risk devices and are therefore subject to the highest level of regulatory control. Class III devices must typically be approved by FDA before they are marketed. For example, replacement heart valves are classified as Class III devices.
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Premarket Notification (510K)

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Who wants to market in the U.S., a Class I, II, and III device intended for human use, for which a Premarket Approval (PMA) is not required, must submit a 510(k) to FDA unless the device is exempt from 510(k) requirements of the Federal Food, Drug, and Cosmetic Act (the Act) and does not exceed the limitations of exemptions in .9 of the device classification regulation chapters.

A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA.

We are here to assist you to US federal law and complete 510(k) applications successfully and fast.

Technical File submission as per 93/42/EEC requirements for CE Marking

  • The MDD is intended to harmonize the laws relating to medical devices within the European Union
  • The MD Directive is a ‘New Approach’ Directive and consequently in order for a manufacturer to legally place a medical device on the European market the requirements of the MD Directive have to be met.
  • Manufacturers’ products meeting ‘harmonized standards have a presumption of conformity to the MDD.
  • Products conforming with the MDD must have a CE mark applied.

Medical Device Directive (MDD) – 93/42/EEC

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  • CE Marking is the symbol as shown on the above of this page. The letters “CE” are the abbreviation of French phrase “Conformité Européene” which literally means “European Conformity”.
  • CE Marking on a product is a manufacturer’s declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation, in practice by many of the so-called Product Directives.
  • CE Marking on a product indicates to governmental officials that the product may be legally placed on the market in their country.
  • CE Marking on a product ensures the free movement of the product within the EFTA & European Union (EU) single market (total 28 countries), and
  • CE Marking on a product permits the withdrawal of the non-conforming products by customs and enforcement/vigilance authorities

Product Classification

  • According to Annex IX of the MDD medical device are classified into one of the four classes.
    Class I,
    Class IIa,
    Class IIb, and
    Class III
  • As per Annex IX
    ,Rule# 1, 2, 3, 4 – Non invasive devices
    Rule# 5, 6, 7, 8 – Invasive devices
    Rule# 9, 10, 11, 12 – Active devices
    Rule# 13, 14, 15, 16, 17, 18 – Special rules
  • We provide the service to implement the System in the organization and as well as getting the CE Mark from the different Certification bodies.
  • The major role of consultants explained here. Customers have the option of choosing any of the option along based on your requirement, but normally we recommend our customers to utilize our services completely.
  • We are here to assist you to construct the Technical File as per the MDD requirements

Computer System Validation(USFDA 21 CFR Part 11)

  • The FDA and other regulatory agencies have established criteria for software-based applications developed for use within the pharmaceutical, biological, and medical device industries. CDAQI team have experience with computer system validation activities and provide services as per customer needs.
  • CDAQI will guide you in the following aspects:
    1. 21 CFR Part 11 Regulatory Documents
    2. 21 CFR Part 11 Electronic Records and Signatures
    3. Guidance for Industry: Part 11: Electronic Records; Electronic Signatures – Scope and Application
    4. General Principles of Software Validation; Guidance for Industry and FDA Staff
    5. Off-The-Shelf Software Used In Medical Devices
    6. Key Concepts About 21 CFR Part 11, Electronic Records and Signatures
  • Contact us today for computer verification and validation review for your company.

Computer System Validation(USFDA 21 CFR Part 11

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ISO 14971 Risk Management

  • The risk management process presented in ISO 14971 includes:
  • Identifying hazards and hazardous conditions associated with a medical device that could place patients or healthcare workers at risk.
  • Estimating the potential occurrence of such risks, and evaluating the extent of the consequences.
  • Developing and implementing active safeguards within the device or the production process to control risks.
  • Regularly reviewing and monitoring the process to assess the effectiveness of risk management controls and the risk management process.
  •   Each aspect of a risk management system is thoroughly documented to provide evidence of the manufacturer’s commitment to control risk throughout the entire life of a given medical device design.
  • CDAQi experts have extensive experience in every aspect of risk management systems for medical device manufacturers in accordance with ISO 14971, and conduct thousands of in-depth risk management audits each year.
  • We provide assistance in association with SJIM and KSMA in various risk  management techniques

1. Event tree analysis (ETA)
2. Fault tree analysis (FTA)
3. Hazard analysis and critical control points (HACCP)
4. Preliminary hazard analysis (PHA)
5. Hazard and operability studies (HAZOP)

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